Surgical templates

ABSTRACT

A surgical template system for use in working on a bone comprises: a tool guide block comprising at least one guide aperture for receiving and guiding a tool to work on a bone; locating means comprising a plurality of locating members, each member having a respective end surface for positioning against a surface of the bone; and attachment means for non-adjustably attaching the tool guide block to the locating means such that, when attached, the member end surfaces are secured in fixed position with, respect to each other, for engaging different respective portions of the surface of the bone, and the at least one guide aperture is secured in a fixed position with respect to the end surfaces. Corresponding methods of manufacturing a surgical template system, methods of manufacturing locating means for a surgical template system, methods of fitting a prosthesis to a bone, surgical methods, and surgical apparatus are described.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Divisional of U.S. patent application Ser. No.15/985,564, filed May 21, 2018, which in turn is a Continuation ofapplication Ser. No. 15/491,853, filed on Apr. 19, 2017, now U.S. Pat.No. 9,974,551, which is a Continuation of application Ser. No.15/012,550, filed on Feb. 1, 2016, now abandoned, which is aContinuation of application Ser. No. 14/531,825, filed on Nov. 3, 2014,now U.S. Pat. No. 9,265,511, which is a Continuation of application Ser.No. 13/937,079, filed on Jul. 8, 2013, now U.S. Pat. No. 9,125,675,which is a Continuation of application Ser. No. 12/532,817, filed onMar. 11, 2010, now U.S. Pat. No. 8,496,663, as a national stage filingof PCT Application No. PCT/GB2008/000988 on Mar. 20, 2008. The priorityof said PCT patent application is claimed. Each of the prior mentionedapplications is hereby incorporated by reference herein in its entirety.

FIELD OF THE INVENTION

The present invention relates to surgical template systems for use inworking on bones, and in particular, although not exclusively, tosurgical template systems for use in total knee replacement surgery.

BACKGROUND TO THE INVENTION

Surgical template systems for use in working on bones, and for preparingbones to receive prosthetics are known.

WO 2004/017842 A2 discloses template systems for use in total kneereplacement surgery. The template systems comprise an adjustablepositioning block and a surgical tool guide. The systems are designed toallow further adjustment after placement on the bone and have mechanismswhich allow this to occur. Disclosed positioning blocks sit on articularsurfaces of bones, and this may lead to inaccuracies in placement. Adisclosed adjustable positioning block comprises a tracker member which,in use, is tracked by a camera-based optical computer assisted surgery(CAS) system to assist the surgeon in correctly positioning the templatesystem. Thus, use of the template systems entails adjustments of atleast the positioning block in the operating theatre. This isdisadvantageous because it is likely to increase both the complexity andtime of the implantation procedure and adds to the number ofintra-operative decisions to be made by the surgeon. Furthermore, theapparatus of the template system itself and the associated trackingequipment is complex and costly. Adjustable mechanisms are moreexpensive to manufacture than fixed, non-adjustable systems, are moreprone to failure, and are harder to clean after use.

WO 2006/060795 A1 discloses a surgical template comprising an alignmentguide, in the form of a mold having a surface for engaging a jointsurface, and an instrument guide, comprising one or more tool-guidingapertures, that communicates with the mold. The mold (alignment guide)may be designed specifically for a given patient and is used to helporientate an instrument guide relative to the patient's anatomy. Forknee surgery, each mold is adapted to conform to an articular surface ofthe femur or tibia. The instrument guide may be manufactured from a hardmaterial and may be re-usable, whereas the alignment guide may be formedfrom a relatively soft material. Optional adjustment between thealignment device and the instrument guide during the surgical procedureis disclosed. Optional use of a metal insert in an opening in a plasticmold to accept a reamer or saw is disclosed. Where the instrument guideis positioned over the mold, such that a tool guided by the instrumentguide needs to pass through the mold to reach the bone beneath, thedocument discloses the option of arranging for openings in the plasticmold (alignment guide), corresponding to the instrument guide openingpositions, to be oversized to avoid introducing plastic debris into thejoint being worked on. Disadvantages of the disclosed templates includethe following. The custom (patient-specific) mold parts of both thefemoral and tibial devices are adapted to conform with and sit on theirarticular surfaces. This can lead to inaccuracies in placement. Duringknee surgery the oscillating saw blade causes any device in contact withthe joint to vibrate. In the disclosed systems in which the instrumentguide blocks sit directly on top of the moulded parts, a problem is howto fasten the guide block to the mold so as not to come apart whilst thebone cuts are made. Positioning the instrument guide block on top of(over) a custom mold can move a guide aperture away from the bonesurface, and can thus result in reduced accuracy when using thataperture to guide a cut. Furthermore, relatively thin (in terms of thedepth of guide aperture provided) instrument guide blocks are disclosed,and by providing relatively shallow guide apertures, the accuracy of thebone cuts that can be made using those guide apertures if reduced. Thisis also exacerbated when the instrument guide block is located over themold, such that a guided tool must also pass through the mold to reachthe bone as the saw blade passes through the slits in them. The tibialand femoral devices sitting over the articular surfaces restrict thevisibility of the surgeon whilst performing the bone cuts. A disclosedfemoral mold, adapted to conform to the femoral articular surface, wouldappear to have to be made from flexible material to fit onto the end ofthe femur (which is, as a rough approximation, bell shaped). A flexiblemold cannot be used to provide rigid location for an instrument guideblock, and hence further inaccuracies in cutting the bone areintroduced.

The paper “Computer-assisted Total Knee Arthroplasty UsingPatient-specific Templating”, M. A. Hafez et al, Clinical Orthopaedicsand Related Research, No. 444, pp. 184-192 discloses femoral and tibialtemplates for total knee replacement surgery. This paper discloses onefemoral and one tibial template, each customized to an individual boneby a process comprising scanning, and each then manufactured by a rapidprototyping technique. Each template is a one-piece block, comprisinglocators having surfaces adapted to seat the template in a uniqueposition on the respective bone, and also comprising guide slots andholes to guide saw blades and drill bits to work on the bone. Eachtemplate is designed for single use (i.e. after that use it is disposedof). The paper discloses use of the templates to perform total kneearthroplasties on cadaveric and plastic knees only. The templates areproduced from a Polyamide (nylon) composite material (DuraForm™, 3DSystems), which is a durable material for creating functional (tooling)prototypes. This material is licensed for in vivo exposure, i.e. cominginto contact with tissue when used as an instrument, but not as animplant. Once manufactured, the templates are sterilized and ready foruse. The paper demonstrates the usefulness and some of the advantages ofpatient specific templates. However, disadvantages of the disclosedtemplates include the following. The relatively soft material used toform each of the single unit templates, and which therefore forms thewalls of the guide apertures, readily sheds particulate material when incontact with moving tool bits (e.g. saw blades, drill bits), which isunacceptable as it might in the long term have an undesirable toxiceffect on the tissues of a patient. Further, the particulate mattermight cause damage to the plastic prosthetic component if trappedbetween the two prosthetic components while they are in use. Frictionbetween the moving surgical tools and the device can cause furthershedding of particulate material from the device and would generatesufficient heat that can melt DuraForm™ under normal operatingconditions. This melting of the device material can cause seizure of thecutting tool. DuraForm™ is porous. The inclusions in the material may be‘opened up’ during surgery by the movement of powered surgical toolsover its surface resulting in the release of more particulate materialwith the consequences stated above. It is now possible to rapidprototype customized devices using stainless steel resulting innon-porous devices. However, constructing each device as a single unit,for the purpose of single use is extremely expensive and this option istherefore not likely to be cost effective. Lastly, the templatesdisclosed in the paper are relatively bulky, and substantially reducevisibility of the femur and tibia being worked on.

Embodiments of the present invention aim to obviate or mitigate at leastone of the problems associated with the prior art.

SUMMARY OF THE INVENTION

According to a first aspect of the present invention there is provided asurgical template system for use in working on a bone, comprising:

-   -   a tool guide block comprising at least one guide aperture for        receiving and guiding a tool to work on a bone;    -   locating means comprising a plurality of locating members, each        member having a respective end surface for positioning against a        surface of the bone; and    -   attachment means for non-adjustably (and, preferably,        releasably) attaching the tool guide block to the locating means        such that, when attached, the member end surfaces are secured in        fixed position with respect to each other, for engaging        different respective portions of the surface of the bone, and        the at least one guide aperture is secured in a fixed position        with respect to the end surfaces.

As the locating means and tool guide block are separate from one another(and must be assembled and attached together to use the template) theycan be manufactured separately and this provides a number of advantages.Firstly the tool guide block may be manufactured as a hard-wearing,reusable component that is not patient-specific. It can, for example, bemanufactured from a metal, such that the guide apertures have hard metalsurfaces which can guide a moving tool (such as a vibrating orreciprocating saw blade or rotating drill bit) without sheddingmaterial. The locating means can be made separately, by differenttechniques and, for example, using different material. For example, thelocating means may be manufactured using rapid prototyping techniques soas to be patient-specific, based on a predetermined bone shape, that isa bone shape, topography or geometry that has been determined by asuitable technique on the patient, such as by scanning (which may alsobe referred to as imaging). Thus, a patient-specific system can beproduced by rapid prototyping of just the locating means, and not thetool guide block. This helps speed up the process and also reducescosts. In other words, embodiments of the invention offer the advantagethat just some parts of the template system need be patient-specific,with other parts being “standard” i.e. predetermined and possiblyreusable components. Advantageously, as the guide aperture or aperturesare provided in the tool guide block and not in the patient-specific“custom” locating means, material can be used for the locating meansthat is suited to the patient-specific manufacturing technique (forexample it may be a relatively soft plastic) whilst avoiding the problemof locating means material shedding during use, as the tools are guidedby the guide block apertures.

It will be appreciated that the locating members of the locating meansare rigid such that the assembled guide block and locating means seatssecurely on a bone to be worked on in a predetermined, defined position.

In certain embodiments the attachment means is adapted to releasably andnon-adjustably attach the tool guide block to the locating means.

In certain embodiments the locating means is adapted such that whenattached to the tool guide block the locating member end surfacesconform to different respective portions of a predetermined bone surfaceand enable the attached locating means and tool guide block to be seatedin a defined position with respect to said predetermined bone surface,with each member end surface in contact with its respective portion ofthe bone surface.

In certain embodiments the locating means has been manufactured using amethod comprising:

-   -   determining a surface shape (topography, geometry) of a bone to        be worked on;    -   manufacturing the locating means according to the determined        shape such that when the locating means is attached to the tool        guide block the locating member end surfaces conform to        different respective portions of the bone surface and enable the        attached locating means and tool guide block to be seated in a        defined position with respect to the bone, with each member end        surface in contact with its respective portion of the bone        surface.

In certain embodiments the locating means is patient specific, in thatthe end surfaces of the locating members are adapted to conform to apredetermined surface of a specific bone of a patient when the locatingmeans is attached to the tool guide block, so as to enable the attachedlocating means and tool guide block to be seated in a defined positionwith respect to the specific bone, with each member end surface incontact with a respective portion of the bone surface.

A plurality of the member end surfaces may be adapted to be in contactwith respective portions of a non-articular surface of the bone when theattached locating means and tool guide block are seated in said definedposition. In certain embodiments all of the locating members arearranged to seat against non-articular surfaces of the bone. This isadvantageous, because in general the non-articular surface can be moreprecisely determined from scanning, and thus enables the template to bemanufactured such that it locates on the bone in a substantially uniqueposition. However, in certain other embodiments, at least one of thelocating member end surfaces is adapted to seat against an articularsurface of the bone.

In certain embodiments the tool guide block is formed from a firstmaterial and the locating means is formed from a second, differentmaterial, and the first material may be harder than the second material.For example, the tool guide block may be formed from a metal, and thelocating means may be formed from a non-metallic material, such as aplastic.

The locating means may have been formed by a rapid prototypingtechnique, e.g. from a non-metallic or a metallic material. Althoughrapid prototyping in metal is currently expensive, only thepatient-specific locating means would need to be formed in this way, notthe tool guide block as well. Thus, rapid prototyping of just thelocating means in metal could be performed, at lower cost than if aunitary guide block and locating means were produced with such atechnique. However, in many embodiments, the locating means is rapidlyprototyped in non-metallic material.

In certain embodiments at least one of the locating members is generallycylindrical and/generally elongate. At least one of the locating membersmay be a locating finger.

In certain embodiments the locating means and guide block are arrangedsuch that, when attached together, the/or each guide aperture isarranged to guide a tool so as to avoid the locating means. This avoidsthe shedding problem, even if the locating means is formed from aplastic or other relatively soft material.

The system may further comprise securing means for securing the attachedlocating means and tool guide block to a bone to be worked on. Forexample, at least one said member may comprise a bore extending throughthe member to the member's end surface, and the securing means maycomprise a pin adapted to extend through the bore so as to be drivableinto a bone surface to pin the member to the bone. Certain embodimentsfurther comprise a sleeve arranged to line said bore, wherein the pin isadapted to extend through the sleeve. A plurality of said members (someor all) may comprise bores, and the securing means then comprises acorresponding plurality of pins.

In certain embodiments, the securing means comprises a bore extendingthrough the tool guide block, and the system further comprises a pinadapted to extend through the guide block bore so as to be insertableinto a bone surface to pin the guide block to the bone. The pin may beadapted so that it can be driven into the bone (for example with blowsfrom a hammer or mallet). However, in alternative embodiments, the pinmay be adapted to screw into the bone. As the tool guide block can bemanufactured from material which does not pose any shedding problemswhen in contact with a moving (e.g. rotating) pin such embodiments ofthe invention can provide clear advantages. The use of one or moresecuring bores and corresponding pins in the tool guide block itself canbe in addition to bores and pins on the locating means, or analternative. Thus, in certain embodiments the tool guide block may besecured to the bone independently of the locating means. In certainexamples, having secured the tool guide block in this way at a positiondetermined initially by the locating means, the locating means may beremoved.

In certain embodiments the tool guide block comprises a plurality ofsecuring bores and corresponding pins. In certain examples, thisplurality of bores comprises a pair of parallel bores arranged such thatwhen their respective pins are inserted into the bone they constrain thetool guide block in directions transverse to the bores but not in adirection along those bores. In certain cases, if the locating means isdetached from the tool guide block the tool guide block may then be slidoff the parallel attachment pins, and if desired could be replaced byanother tool guide block with one or more tool guide apertures arrangedto provide cutting or drilling (or otherwise working) on the bone at amodified position.

In certain embodiments each bore extending through a member is arrangedso as to be generally perpendicular to a respective portion of thesurface of a predetermined bone against which the respective end surfaceis adapted to seat. This helps the pins to be driven into the bonewithout skidding, so maintaining the accurate placement of the templatesystem on the bone.

In certain embodiments the locating means and guide block are arrangedsuch that, when attached together, the/or each guide aperture isarranged to guide a tool so as to avoid the locating means and the oreach pin when driven into a bone surface. In other words, the system isdesigned so that the locating members and pins driven through the boresavoid any of the cut surfaces and holes that are produced when the guideapertures are used.

In certain embodiments, at least one guide aperture comprises at leastone slot for guiding a saw blade. The slot may be an open-ended slot.This facilitates insertion of a saw blade into the slot and also enablesthe overall size of the guide block to be reduced as slot-closingmaterial at at least one end of the slot is dispensed with. It alsoallows completion of the bone cuts without the need to remove theattached template.

At least one guide aperture may be a hole for guiding a drill bit, andin certain embodiments the tool guide block comprises a plurality ofguide apertures.

The locating members may be separate components, and the relativepositions of their end surfaces may only be defined when they areattached to the tool guide block. However, in certain other embodimentsthe locating means comprises a body portion with a plurality of thelocating members attached to that body portion and extending from it totheir respective end surfaces. The attachment means may then be adaptedto attach the body portion to the tool guide block. The body portion andthe locating members extending from it may be integral. By manufacturingthis body portion and plurality of locating members as a single unit,this provides the advantage that the relative positions of the endsurfaces of those members extending from the body portion are completelyfixed, even before the body portion is attached to the tool guide block.Thus, their relative positions cannot be affected by any tolerancesinvolved in attachment of the body portion to the guide block, and hencethe integral body portion and locating members help seat the assembledtemplate system in the desired, substantially unique position on thebone.

Achieving placement of a customised template component on its respectivebone requires careful consideration of the number and position of thelocators. The following applies to the component customised for thefemoral bone, but it will be appreciated that the general features maybe applicable to other bones. The customised template component may havefour locators, two on the medial side and two on the lateral side. Whilethe template component might be placed such that the four locators aresimultaneously in contact with the bone, there is still the possibilitythat the template may be incorrectly placed; because of the presence ofa slippery soft tissue layer (albeit thin) on the bone surfaces, thismay render the contact between the locators and bone surfaces to be softand consequently the template may be pushed further in the posterior andinferior directions, thus resulting in inaccuracies in cutting the bone.This can have serious consequences, especially if the movement in theposterior direction is large, as it could result in violating theanterior cortex of the femur. For this reason, in another embodiment ofthe invention there may be included two additional locators, each ofwhich may be arranged to limit the movement of the template in one ofthe two directions mentioned above. During surgery, should either ofthese additional locators be in contact with soft tissue, the lattercould be removed so that the locator is in contact with bone. Thisconcept is also applicable to the tibial template, and of course toother templates for working on other bones. Thus, during surgery, if itis determined that a locator would be seated on relatively softmaterial, the surgeon may remove the soft material with a scalpel so asto properly seat the locator on a hard bone surface.

In certain embodiments the locating means further comprises anadditional locating member having an end surface for positioning againsta bone surface, and means for releasably attaching the additionallocating member to the body portion such that the additional locatingmember extends from the body portion to its end surface, whereby theadditional locating member may be attached to the body portion to assistin seating the attached locating means and guide block against a bone tobe worked on, and then removed to facilitate working on the bone.Whereas the other locating members may be arranged so that they areavoided by tools guided by the guide aperture or apertures in the toolguide block, the additional locating member may not be avoided, forexample it may be in line with a guide slot such that a saw blade guidedby that slot would intersect the additional locating member. However, asthe additional locating member is releasably attached, it can be removedafter locating the assembled template system on the bone and securing itin place. In this manner it can assist a surgeon in positively locatingthe template system on the bone in the required position and yet, bybeing removable, still avoids the potential shedding and contaminationproblems.

In certain embodiments the body portion and guide block are adapted tokey together in a defined position, so as to assist in fixing therelative positions of locator end surfaces and guide apertures.

The attachment means may, for example, comprise at least one screw orbolt.

In certain embodiments the attachment means comprises a snap-fitmechanism. This may be arranged to allow the custom and re-usable partsto be securely and quickly attached to one another without the use ofbolts or screws (or alternatively could be used in addition to bolts orscrews). In certain examples, the snap-fit mechanism may be such thatadditional devices may be required to separate the two components onceattached (or to bring the components together). In certain embodiments,in order to separate the custom part (locating means) from there-useable part (tool guide block) it may be necessary to break thecustom part (or at least some component, element or part of the snap-fitmechanism). It is conceivable that in further alternative embodiments,the locating means may be removable from the tool guide block inalternative ways, for example by dissolving the locating means material.

In certain embodiments the tool guide block comprises a first portionincluding at least one guide aperture and a second portion including atleast one guide aperture. The tool guide block may then further comprisea connecting portion, connecting said first portion to the secondportion, and this 5 connecting portion may be adapted to improvevisibility of the joint being worked on. For example, it could beperforated, transparent, or have reduced width and/or thickness comparedwith the first and second portions. It could have a depth greater thanits width, said depth being in a direction generally toward the bone tobe worked on, and said width being in a direction generally transverseto the bone. It may, for example be provided by a single web.

Thus, the connecting portion may comprise a web. This web may also bedescribed as an arm. By connecting the first and second portions using asingle web or arm, the surgeon is provided with improved access andvisibility of the bone being worked on. It will be appreciated that theweb or arm must provide rigid connection of the first and secondportions so that the relative positions of the respective guideapertures are fixed and well defined. The separate guide block andlocating means of embodiments of the invention makes this possiblebecause suitable materials for forming a rigid connecting web can beused in the manufacture of the guide block and which would be unsuitedto the manufacture of the patient-specific locating means. Inparticular, the first, second, and connecting web portions of the guideblock may be manufactured from a metal, and may indeed be manufacturedas a single, integral unit. At least one of the guide apertures may be aslot having a length, and the web may have a thickness substantiallysmaller than that length.

In certain embodiments first portion comprises at least one slot forguiding a saw blade to make a cut in a plane, and said second portioncomprises at least one slot or guide hole for guiding a saw blade ordrill bit respectively to make a cut or hole in a directionsubstantially perpendicular to said plane.

The first portion may include a guide slot for guiding a saw blade tocut off an end portion of a bone against which the assembled locatingmeans and guide block are positioned and said second portion includes aplurality of guide holes to guide a drill bit to drill into the sawn endsurface.

In certain embodiments the system is a femoral system (i.e. for workingon a femur), in which the locating means is arranged such that, whenattached to the tool guide block, the member end surfaces am positionedto seat the locating means and guide block in a predetermined positionon a specific femur by engaging non-articular surface portions of thefemur. The tool guide block may then comprise a first portion includinga guide slot for guiding a saw blade to cut off an end portion of thefemur to leave a sawn end surface when the block and locating means areseated in the predetermined position, and a second portion including aplurality of guide holes to guide a drill bit to drill into the sawn endsurface. The second portion may further comprise at least one guide slotfor guiding a saw blade to make at least one further cut in the femur.The locating means may comprise an additional locating member having anend surface for positioning against a non-articular anterior surface(i.e. the cortical bone surface just above the trochlea; this may bemore accurate than just seating against the trochlea, as this may wellhave cartilage residues, as thick as 2-4 mm, that would affect theaccuracy) of the femur. Advantageously, this additional locating memberadapted to sit on the above mentioned anterior cortical bone surface ofthe femur may be arranged so that it extends through a cut plane definedby one of the guide slots in the guide block. By positioning the end ofthe additional locating member against the said anterior surface of thefemur to locate the assembled template system in the required position,this then ensures that the above-mentioned cut plane is away from theanterior surface (ensuring that the saw blade when guided by thataperture does not violate the anterior cortex of the bone). Theadditional locating member can then be removed after the template systemhas been secured in place. Thus, the system may further comprise meansfor releasably securing the additional locating member with respect tothe guide block and locating member end surfaces, whereby the additionallocating member may be secured in place to assist in seating theattached locating means and guide block against the femur, and thenremoved to facilitate working on the femur.

Other embodiments provide a tibial template system, in which thelocating means is arranged such that, when attached to the tool guideblock, a plurality of said member end surfaces are positioned to seatthe locating means and guide block in a predetermined position on aspecific tibia by engaging non-articular surface portions of the tibia.It may employ further locators to seat on articular surface portions aswell.

In certain embodiments the locating means comprises a first body portionand a first plurality of said locating members extending from the firstbody portion to their respective end surfaces, and a separate secondbody portion and a second plurality of said locating members extendingfrom the second body portion to their respective end surfaces, and theattachment means is adapted to attach said first body portion to thetool guide block and said second body portion to the tool guide block.The first body portion and the first plurality of said locating membersmay be integral, as may the second body portion and the second pluralityof locating members.

In certain embodiments the tool guide block comprises a first portionincluding at least one guide aperture and a second portion including atleast one guide aperture, the tool guide block further comprises aconnecting portion connecting said first portion to the second portion,and the attachment means is adapted to attach said first body portion tothe first portion of the tool guide block and said second body portionto the second portion of the tool guide block. The first portion of theguide block may be adapted to extend around an arc of less than 100degrees and/or may be generally arcuate. The connecting portion maycomprise a web portion connected at or proximal one end of the firstportion. Thus, the guide block may be asymmetrical, being suited to usein surgery on the bone requiring access to the bone from essentiallyjust one quadrant.

In certain embodiments the second portion of the guide block comprises acomposite guide aperture comprising a hole portion for guiding a drillbit to drill a hole in a bone, and at least one slot portion for guidinga saw blade to make a cut extending from said hole.

Certain embodiments are adapted for working on a tibia, wherein the endsurfaces of the first plurality of locating members are adapted to seaton respective portions of a non-articular surface of a specific tibiaand the end surfaces of the second plurality of locating members areadapted to seat on respective portions of an articular surface of thespecific tibia.

In certain embodiments the tool guide block is a first tool guide block,the system further comprising a second tool guide block including atleast one additional guide aperture. Such an arrangement is particularlysuited to the requirements of minimally invasive surgery because thetotal number of guide apertures required to guide tools to prepare thebone in a desired manner to receive a prosthesis can be split betweenthe first and the second blocks, thus enabling each block to be madesubstantially smaller than the single block that would otherwise berequired to define all of the necessary guide apertures. It alsoprovides the advantage that, as the first guide block provides only oneor some of the guide apertures, rather than all of them, it givesgreater freedom in the locating means manufacturing process to provide aplurality of locating members to securely seat the template system inthe required position whilst keeping those locating members out of theway of tools guided by the guide aperture or apertures. In other words,the two-block template system provides a greater degree of flexibilityduring the custom locating means design process.

The first tool guide block may comprise at least one guide slot forguiding a saw blade to cut a bone to provide a flat surface and at leastone guide hole to guide a drill bit to drill at least one hole in theflat surface, and the second tool guide block has a flat surface adaptedto sit on the bone flat surface prepared using the first tool guideblock and comprises at least one protruding member extending from theblock flat surface to locate in the at least one hole, to locate thesecond guide block on the bone flat surface.

In certain embodiments the first tool guide block further comprisesmounting means for mounting the second guide block on the first guideblock after the first guide block has been used to guide at least onetool to work on the bone.

In certain embodiments the locating means comprises an additional bodyportion and at least one additional locating protrusion extending fromthe additional body portion and having an additional end surface forlocating against an additional bone surface portion to help seat thelocating means and attached guide block on the bone, and wherein theattachment means is adapted to releasably and non-adjustably attach theadditional body portion to the guide block.

In certain embodiments the locating means further comprises at least onefeature having a dimension measurable to check a manufacturing accuracyof the locating means.

In certain embodiments, the locating means further comprises at leastone paid of indicia having a separation measurable to check themanufacturing accuracy of the locating means.

In certain embodiments, the system further comprises a gauge adapted toengage the locating means to provide a check on a manufacturing accuracyof the locating means. The locating means may comprise at least onefeature adapted to mate with the gauge to provide this check.

Another aspect of the present invention provides a method ofmanufacturing a surgical template system for use in working on a bone,the template system comprising a tool guide block comprising at leastone guide aperture for receiving and guiding a tool to work on a bone,locating means comprising a plurality of locating members, each memberhaving a respective end surface for positioning against a surface of thebone, and attachment means for non-adjustably (and, preferablyreleasably) attaching the tool guide block to the locating means suchthat, when attached, the member end surfaces are secure in fixedposition with respect to each other, for engaging different respectiveportions of the surface of the bone, and the at least one guide apertureis secured in a fixed position with respect to the end surfaces, themanufacturing method comprising:

-   -   determining a surface shape of a bone to be worked on;    -   manufacturing the locating means according to the determined        shape such that when the locating means is attached to the tool        guide block the locating member end surfaces conform to        different respective portions of the bone surface and enable the        attached locating means and tool guide block to be seated in a        defined position with respect to the bone, with each member end        surface in contact with its respective portion of the bone        surface.

In certain embodiments, the manufacturing of the locating means furthercomprises manufacturing the locating means according to the determinedshape such that a plurality of said member end surfaces are adapted tobe in contact with respective portions of a non-articular surface of thebone when the attached locating means and tool guide block are seated insaid defined position.

At least one member end surface may be adapted to be in contact with aportion of an articular surface of the bone when the attached locatingmeans and tool guide block are seated in said defined position.

The method may comprise manufacturing the tool guide block from a firstmaterial (e.g. a metal) and manufacturing the locating means from asecond, different material (e.g. using a rapid prototyping technique).

In certain embodiments the method further comprises manufacturing thelocating means and guide block such that, when attached together, the/oreach guide aperture is arranged to guide a tool so as to avoid thelocating means. At least one member may be manufactured to comprise abore, such that a pin can be driven through the bore into the bonesurface to secure the locating means to the bone, and each guideaperture may then be arranged to guide a tool so as to avoid the or eachpin driven into the bone through a respective bore. In certainembodiments each bore is arranged so as to be generally perpendicular toa respective portion of the surface of said bone against which therespective end surface is adapted to seat.

In certain embodiments, manufacturing the locating means comprisesmanufacturing a body portion and a plurality of said locating membersattached to and extending from the body portion to their respective endsurfaces, for example as an integral unit.

In certain embodiments, manufacturing the locating means furthercomprises manufacturing an additional locating member according to thedetermined shape, the additional locating member having an end surfacefor positioning against the bone surface, and the method furthercomprises providing means for releasably attaching the additionallocating member to the body portion such that the additional locatingmember extends from the body portion to its end surface, whereby theadditional locating member may be attached to the body portion to assistin seating the attached locating means and guide block against the boneto be worked on, and then removed to facilitate working on the bone.

In certain embodiments the tool guide block comprises a first portion,comprising at least one guide aperture, a second portion, comprising atleast one guide aperture, and a connecting portion connecting said firstportion to the second portion, the method comprising manufacturing thefirst, second, and connecting portions as an integral unit.

In certain embodiments the bone is a femur. The additional locatingmember end surface may then be arranged for positioning against ananterior surface of the femur.

In certain other embodiments the bone is a tibia.

The locating means may be manufactured such that, when attached to thetool guide block, a plurality of said member end surfaces are positionedto seat the locating means and guide block in a predetermined positionon the bone by engaging non-articular surface portions of the bone, andoptionally such that another plurality of said member end surfaces arepositioned to seat the locating means and guide block in a predeterminedposition by engaging articular surface portions of the bone.

In certain embodiments manufacturing the locating means comprisesmanufacturing a first body portion and an integral first plurality ofsaid locating members extending from the first body portion to theirrespective end surfaces, and a separate second body portion and anintegral second plurality of said locating members extending from thesecond body portion to their respective end surfaces.

In certain embodiments, said step of determining a surface shape of thebone comprises non-invasive scanning of a patient.

Another aspect of the invention provides a method of manufacturinglocating means for a surgical template system for use in working on abone, the template system comprising a tool guide block comprising atleast one guide aperture for receiving and guiding a tool to work on abone, locating means comprising a plurality of locating members, eachmember having a respective end surface for positioning against a surfaceof the bone, and attachment means for non-adjustably (and, preferably,releasably) attaching the tool guide block to the locating means suchthat, when attached, the member end surfaces are secured in fixedposition with respect to each other, for engaging different respectiveportions of the surface of the bone, and the at least one guide apertureis secured in a fixed position with respect to the end surfaces, themanufacturing method comprising:

-   -   determining a surface shape of a bone to be worked on;    -   manufacturing the locating means according to the determined        shape such that when the locating means is attached to the tool        guide block the locating member end surfaces conform to        different respective portions of the bone surface and enable the        attached locating means and tool guide block to be seated in a        defined position with respect to the bone, with each member end        surface in contact with its respective portion of the bone        surface.

In certain embodiments of these methods, manufacturing the locatingmeans comprises manufacturing at least one feature having a dimension,or at least one pair of indicia having a separation, measurable todetermine a manufacturing accuracy of the locating means.

In certain embodiments, this at least one feature or pair of indicia isprovided on the locating means itself. In alternative embodiments, thefeature or pair of indicia may be provided on a portion of materialattached to the locating means and manufactured integrally with thelocating means. This portion of material may thus be described as anindicator, manufactured together with the locating means, and before thelocating means is used in surgery this indicator may be detached fromthe locating means.

Another aspect of the invention provides a method of fitting aprosthesis to a bone, the method comprising:

-   -   manufacturing a surgical template system using a method in        accordance with another aspect of the invention;    -   using the attachment means to attach the locating means to the        tool guide block;    -   arranging the attached locating means and tool guide block such        that they are seated in the defined position with respect to the        bone;    -   using the at least one guide aperture to guide a tool to work on        the bone to prepare the bone for receiving the prosthesis; and    -   fitting the prosthesis to the prepared bone.

The method may further comprise scanning a patient to determine thesurface shape of the bone, and selecting the prosthesis from a pluralityof prostheses. This plurality of prostheses may include prostheseshaving a variety of different sizes.

The method may further comprise selecting a desired position for theprosthesis relative to the bone.

In certain embodiments the method further comprises forming a virtualmodel of the bone and manipulating a virtual model of the selectedprosthesis relative to the bone virtual model to determine the desiredposition. The selected prosthesis in certain embodiments has a definedinterior surface shape, and the method further comprises using theselected desired position and the defined interior surface shape todetermine the position of each guide aperture when the assembledtemplate is seated in the defined position on the bone.

The method may further comprise selecting the tool guide block from aplurality of tool guide blocks, the selected block comprising aplurality of guide apertures corresponding to said defined interiorsurface shape.

Another aspect of the invention provides a surgical method comprising:

-   -   manufacturing a surgical template system using a method in        accordance with another aspect of the invention;    -   using the attachment means to attach the locating means to the        tool guide block;    -   arranging the attached locating means and tool guide block such        that they are seated in the defined position with respect to the        bone;    -   using the at least one guide aperture to guide a tool to work on        the bone.

In certain embodiments the method further comprises using the tool guideblock to guide a saw blade to cut a flat surface on the bone and toguide a drill bit to drill at least one locating hole in the cut flatsurface, locating a second guide block on the cut flat surface and atleast one locating hole, and using the second guide block to guide atool to perform further work on the bone.

In certain embodiments the method further comprises mounting a secondtool guide block comprising at least one guide aperture on the firstguide block and using the second guide block to guide a tool to performfurther work on the bone.

Another aspect of the invention provides surgical apparatus comprising:

-   -   locating means for a surgical template system in accordance with        another aspect of the invention; and    -   patient identification means providing an indication of the        patient to whom said bone to be worked on belongs.

In certain embodiments, the patient identification means may be providedon the locating means, but in alternative embodiments the identificationmeans may be linked to the locating means by linking means.

In certain embodiments the locating means comprises locating means for atemplate system for a femur and for a template system for a tibia for aspecific knee joint of a particular patient.

In certain embodiments the locating means, patient identification means,and linking means have been manufactured together using a rapidprototyping technique.

In certain embodiments the surgical apparatus further comprises anindicator, manufactured together and integrally with the locating means,the indicator comprising at least one feature having a dimensionmeasurable to check a manufacturing accuracy of the locating means. Thisindicator may, for example, be separable from the locating means beforethe locating means is used in surgery.

In certain embodiments, the apparatus further comprises a gauge adaptedto engage the indicator and thus provide a quick check of the indicatordimensions and hence the accuracy of manufacture of the integrallyformed locating means before use.

From the above summary, and the following description, it will beappreciated that embodiments of the invention provide a number ofadvantages, as follows. In certain embodiments, a template isessentially split into two components; a “standard” (i.e. non-patient 30specific) cutting block (guide block), which may be made of abiocompatible metal, is attached to a “customized” locating means (whichmay be a block), thus forming a unitary template. The customizedcomponent is designed so as to locate in the unique position for thebone cuts and holes to be made. By making the cutting (guide) block froma biocompatible metal the problem of shedding of potentially harmfulparticulate matter that is associated with DuraForm does not arise.Stainless steel may be used to manufacture the cutting block and is alsorobust enough so as to allow the use of the metallic componentrepeatedly. The locating means (which in certain examples may bedescribed as orientating blocks) can be manufactured with rapidprototyping technologies and are intended for single use. This approachnot only avoids the problems associated with the porosity of structuresmanufactured using rapid prototyping but is more cost effective. Theoptimal position of the prosthesis is determined precisely during thepreoperative planning procedure. The preoperative position of theprosthesis determines the positing of the device relative to thepatient's anatomy. Thus the operative procedure is less complex and maybe achieved in a shorter time. Embodiments of the invention do not need,and so do not include, adjustable mechanisms, and so are less complex tomanufacture, are user friendly and more cost effective. Locators with arelatively small cross sectional area may be used, located upon thetibial plateau with certain tibial device. However, the smallcross-sectional area of these cylinders reduces the errors. Certainminimally invasive tibial devices embodying the invention avoid thearticular surface of the tibia altogether. The separate components ofcertain femoral and tibial devices embodying the invention are securelyfastened by means of a screw so as to form a single unitary device whichwill not vibrate apart during use. Convergent pins securely fasten therelevant device to the appropriate bone. Care can be taken during thepreoperative planning procedure to place the locators perpendicular tothe bone surface. In doing so any possible collisions with the sawblade/drill/adjacent pins are identified and rectified when it isappropriate to do so. In embodiments of the invention, the customlocating means does not sit between the guide block apertures and thebone, so it is possible to design the cutting to be of the requireddepth to ensure accurate cutting of the bone whilst keeping the overallsize of the cutting blocks small. Template systems embodying theinvention are designed to be fitted with both ease and accuracy in aunique position on the appropriate bone. The positioning of eachtemplate system can be tested in the laboratory, before surgery, e.g.virtually tested during the pre-operative planning procedure. Certainembodiments are designed specifically to increase the visibility thesurgeon has of the knee whilst performing the bone cuts. This will notonly increase the appeal of each device to the surgeon but also thesafety of its use.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the invention will now be described, by way of exampleonly, with reference to the accompanying figures, of which:

FIG. 1 a-1 f are views of a surgical template system for use in workingon a femur;

FIGS. 2-2 e are views of the surgical template system from FIG. 1 in usein a surgical method embodying the invention;

FIGS. 3 a-3 e are views of another surgical template system embodyingthe invention for use in working on a tibia;

FIGS. 4 a-4 e are views of the tibial template system of FIG. 3 in usein a surgical method embodying the invention;

FIGS. 5 a-5 d are views of surgical apparatus embodying the invention(that apparatus including patient-specific locators for use in surgicaltemplate systems embodying the invention);

FIGS. 6 a-6 e are views of part of another surgical template systemembodying the invention and for use in working on a femur;

FIGS. 7 a-7 e are views of the apparatus of FIG. 6 in use in a surgicalmethod embodying the invention to prepare a femur for receiving aprosthesis;

FIGS. 8 a-8 f are views of further components of the surgical templatesystem including the apparatus of FIG. 6 ;

FIGS. 9 a-9 e are views of the apparatus of FIG. 8 in use in a surgicalmethod embodying the invention for preparing a femur to receive aprosthesis;

FIGS. 10 a-10 d are views of another surgical template system embodyingthe invention and for use in working on a tibia;

FIGS. 11 a-11 d are views of the template system from FIG. 10 in use ina method embodying the invention;

FIGS. 12 a-12 d are further views of the apparatus from FIG. 10 in usein a tibial preparation method embodying the invention;

FIGS. 13 a-13 d are views of another surgical template system embodyingthe invention and for use in working on a tibia;

FIGS. 14 a-14 d are views of the apparatus of FIG. 13 in use in a methodembodying the invention;

FIGS. 15 a-15 d are views of another surgical template system embodyingthe invention and for use on a tibia;

FIGS. 16 a-16 d are views of the apparatus from FIG. 15 in use in amethod embodying the invention;

FIG. 17 is a flow chart illustrating steps in a surgical methodembodying the present invention;

FIG. 18 is a flow chart illustrating further detail of the preoperativeplanning step from FIG. 17 ;

FIG. 19 is a flow-chart illustrating further detail of the manufacturingstep of a method from FIG. 17 ;

FIG. 20 is a flow chart illustrating further detail of the surgery stepof the method from FIG. 17 ;

FIGS. 21 a-21 e are an end view of a femur end surface, a perspectiveview of the femur end surface before preparation, a perspective view ofa prosthesis, a perspective view of the femur prepared to receive theprosthesis, and a perspective view of the prosthesis fitted to theprepared femur respectively;

FIGS. 22 a-22 e are an end view of the knee joint articular surface of atibia, a perspective view of the end of the tibia, a perspective view ofa tibial prosthesis, a perspective view of the end of the tibia preparedto receive the prosthesis, and a perspective view of the tibialprosthesis fitted to the prepared tibia respectively;

FIGS. 23 a-23 e are views of a bone surface and components of a surgicaltemplate system illustrating steps in the design of customised locatorelements and methods embodying the present invention;

FIG. 24 is a perspective view of another template system embodying theinvention and positioned on a tibia to work on that bone;

FIG. 25 is another view of the template system of FIG. 24 in position ona tibia;

FIG. 26 is a view of another template system embodying the invention andpositioned to work on a tibia;

FIG. 27 is a view of another surgical template system embodying theinvention and positioned to work on a bone;

FIGS. 28 a-28 d are front, left, top, and isometric views respectivelyof a template system embodying the invention positioned on a femur;

FIGS. 29 a-29 d are front, left, top, and isometric views respectivelyof parts of the template system shown in FIG. 28 ;

FIGS. 30 a-30 c are bottom, left, and isometric views respectively of atool guide block of a template system embodying the invention togetherwith a removable locator,

FIG. 31 illustrates another template system embodying the invention;

FIG. 32 illustrates another template system embodying the invention;

FIGS. 33 a-33 d illustrate components of another template systemembodying the invention and positioned with respect to a femur;

FIGS. 34 a-34 c illustrate the locating means of a template systemembodying the invention, the locating means comprising an indicatormeasurable with a gauge or other means to provide a check on themanufacturing accuracy of the locating means;

FIGS. 35 a-35 c are different views of the locating means of anotherembodiment of the invention, the locating means incorporating pairs ofindicia having separations measurable to check a manufacturing accuracyof the locating means before use in surgery; and

FIG. 36 illustrates an indicator manufactured together and integrallywith the locating means of certain embodiments and measurable with agauge or other measurement means to provide a check in three dimensionson the manufacturing accuracy of the locating means before use insurgery.

DETAILED DESCRIPTION OF THE REFERRED EMBODIMENTS

Certain embodiments of the invention may be used in the field of totalknee replacement (TKR) surgery. In one example of TKR surgery, twodifferent assemblies each embodying the invention are used, one for usewith the femur the other with the tibia, to aid the surgeon in cuttingboth of these bones to receive prosthetic knee components.

Each assembly comprises a patient specific orienting block (locatingmeans) and a cutting block (tool guide block), the latter having theappropriate number of slits and holes for guiding moving surgical toolsto make the cuts in the relevant bone accurately and in the correctorientation so as to receive the relevant prosthetic component in theposition that has been determined through the preoperative planningprocedure. Prior to being used in surgery, the orienting and cuttingblocks for each bone are assembled and firmly attached with screws toform rigid unitary guides that locate each in a unique position onto therelevant bone and is firmly pinned to the bone at a number of sites onthe bone to maintain that position during the process of bone cutting.The sites where the pins engage the bone are carefully chosen such thatthey avoid the paths of the saw blade when making the bone cuts.

Detailed views of the femoral and tibial assemblies are provided inFIGS. 1-5 . FIG. 1 illustrates exploded views of the femoral device fromthe front, top, bottom, and side, along with an isometric view. FIG. 2illustrates views of the same device assembled and pinned to the femur.FIG. 3 illustrates exploded views of the tibial device from the front,top, bottom, and sides, along with an isometric view. FIG. 4 illustratesviews of the same device assembled and pinned to the tibia. FIG. 5illustrates front, side, top and isometric views of the customisedcomponents immediately after manufacturing, and the figures showsthese-components kept together as a group, with an additional thinelongate rod that is attached at both ends to a plate containing aunique identification string of alphanumeric characters for eachpatient. Each component within the group will have inscribed on it meansof identification as belonging to this group.

Referring to the labelled views in FIGS. 1 & 2 , the customisedorienting component 1, is located into a protrusion 24 in the reusablemetallic cutting block 2 and firmly attached to it with two screws 3.Countersunk holes 4 on the upper surface of the orientating componentalign precisely with screw threads 5 in the reusable metallic cuttingblock.

Although the customised component 1 is currently constructed fromDuraForm (PA) it is envisaged that it may be constructed from any of anumber of materials that will become available over time. The customisedcomponent includes four locators 6 all of which are intended tosimultaneously contact the bone of the particular patient, and sit on itin a unique position, thus orienting the cutting block in theappropriate position that has been determined in the preoperativeplanning stage so as to achieve with precision the appropriate bone cutsand alignment of the prosthetic component within the bone.

The orienting block is firmly attached to the relevant bone with pins 7through the locators 6. These are positioned during the preoperativeplanning so as to be perpendicular to the bone surface they are incontact with. This ensures the pins 7 do not skid as they are driventhrough the bone surface thus firmly securing the orienting block inplace while the bone is being cut with oscillating saw blades that areguided by the slits 12 in the cutting block.

A removable locator 8 fits onto a protrusion 9 in the orienting blockand is held in place by a square metal peg 10. This removable locator isdesigned so as to come into contact with a non-articular anteriorsurface (i.e. the cortical bone surface just above the trochlea) of thefemur and in doing so insures that the anterior cortex of the femur willnot be violated when making the anterior, since that locator's length isadjusted (during the preoperative planning procedure) so that its tipfalls posterior to the slit in the cutting block through which theanterior cut of the femoral bone is made. The removable locator 8 has ahole 11 close to its top surface. This allows it to be grouped with allof the customized components for a given patient during theirmanufacture (see FIG. 5 ).

The removable locator 8 has to be removed once the saw blade hasadvanced sufficiently into the bone when making the anterior cut inorder to complete that cut.

The bone cuts are accurately made by passing the saw blade through slits12. These slits are aligned with precision to the internal surfaces ofthe relevant femoral prosthesis.

Besides slits for making the bone cuts, the metallic cutting block 2 hastwo holes 13 to guide a drill bit for making holes into both the medialand the lateral condyles of the femur to receive the fixation lugs ofthe prosthesis.

Components of the template system thus include: custom component 1;Standard metallic component 2; Protrusion 24; Metallic screws 3;Countersunk holes in custom component 4; Screw threads 5; Pins 7;Locators 6; Removable locator 8; Protrusion 9 to receive locator 8;Square metal peg 10 to hold 8 to 9; Hole 11 in removable locator; Slits12 to guide saw bade; and Holes 13 to guide drill.

Thus, from the above description of FIGS. 1 and 2 , it will beappreciated that a first surgical template system embodying the presentinvention comprises a tool guide block 2 comprising a plurality of guideapertures 200 for receiving and guiding the tool or tools to work on abone. The system further comprises locating means 1 comprising aplurality of locating members in the form of locating fingers 6, eachfinger having a respective end surface 61 for positioning against asurface of the bone. The template system also includes attachment means3 for releasably and non-adjustably attaching the tool guide block 2 tothe locating means 1. In other words, the securing means 3 secures thelocating means 1 and tool guide block 2 when they are assembledtogether. When the locating means 1 and tool guide block 2 are attachedtogether by the attachment means 3 the finger end surfaces 61 aresecured in fixed position with respect to each other, for engagingdifferent portions of the surface of the bone, and the guide apertures200 are also secured in fixed position with respect to those locatingend surfaces 61. In this first embodiment, the locating means 1 has beenmanufactured using rapid prototyping technique from plastic material.The manufacturing technique has included the step of determining theshape of a femur to be worked on, and the locating finger end surfaces61 are adapted to conform to the particular femur surface and enable theassembled template to be seated in a defined, substantially uniqueposition on that particular femur with the guide apertures 200 thenpositioned so that when cuts and holes are made in the femur theresultant prepared surface conforms to the interior surface of aprosthesis.

In this first example, the locating means 1 comprises a body portion 60and the four fixed locating fingers 6 extend from that body 60 to theirbone-engaging end surfaces 61. In fact, in this example the locatingfingers 6 and body 60 are integral. Thus, as the fingers 6 and body 60are substantially rigid, the positions of the end surfaces 61 are in adefined, fixed relationship to one another even before the attachmentmeans secures the guide block 2 to the locating means 1. However, itwill be appreciated that in alternative embodiments, at least some ofthe locating fingers 6 may be separate from one another, such that theirend surfaces 61 are only in fixed positions with respect to each otherwhen these separate locators 6 have been secured to the guide block 2.

Each of the four rigid locating fingers 6 is substantially cylindricaland elongate, and includes a bore extending through the finger 6 to itsend surface 61. The template system further comprises a plurality ofpins 7, each pin being arranged so as to extend through the bore of arespective locating finger 6 so that it can be driven into the bonesurface against which a template system is positioned to secure thetemplate system to the bone to be worked on. The orientation of thebores has been determined during the template system manufacturingmethod so that each bore is substantially perpendicular to the portionof the bone surface against which its respective locator end surface 61is seated. This helps to ensure that when the pins are driven into thebone they do not skid. An advantage of securing the locating means tothe bone in this way is that the tool guide block of the system is thenrigidly and securely held in place, and will not become unseated evenwhen cutting operations using saws and or drills are being used on thebone.

The locating means 1 and tool guide block 2 in this example are adaptedto key together by means of a block-like protrusion 24 on the guideblock 2 and a corresponding recess 624 in the body 60 of the locatingmeans. The attachment means takes the form of two machine screws orbolts which pass through countersunk holes 4 in the locator body 60 andwhich are then received in a pair of threaded holes 5 in the tool guideblock 2. The machine screws 3 thus releasably and non-adjustably attachthe tool guide block 2 to the locating means 1.

In addition to the four fixed locating fingers 6, the locating meanscomprises an additional, removable locating member 8 having an endsurface 81 for engaging another portion of the femur surface when thetemplate system is in the defined position. In this example, theremovable locator end surface 81 is adapted to sit on an anteriornon-articular surface of the femur. The removable locator 8 is removablymounted on a mount or protrusion 9 extending from the locator body 60and is secured in place by means of a square peg 10. The protrusion 9 isreceived in a corresponding slot on the removable locator 8, and thesquare peg 10 then passes through an end surface of the removablelocator 8 to effectively pin it to the portion of the protrusion 9received in the slot of the locator 8. The removable locator 8 also hasa hole or bore 11 by means of which it can be linked to the otherpatient-specific components during manufacture.

It will be appreciated from the above that, as the locating members(fingers or cylinders) 6 are provided with bores 62 (in other words theyare cannulated for driving pins 7 through them) their end surfaces 61,which are adapted to conform to respective portions of the predeterminedfemur, are annular.

Turning now to the details of the guide block 2 in this first examplethe guide block 2 is metallic. It comprises a first portion 21 whichcomprises a guide aperture in the form of a slot 201 for receiving andguiding a reciprocating saw blade to perform a cutting operation on thefemur against which the template is positioned and secured. This firstportion 21 is the portion of the guide block 2 to which the attachmentmeans 3 attaches the locating means 1. The guide block 2 comprises asecond portion 22 which comprises a plurality of guide slots 12 and aplurality of guide holes 13. The guide slot 201 in the first portion 21enables a saw blade to be guided and used to cut a flat surface on theend of a femur, substantially from a side direction relative to thelongitudinal axis of the bone. The guide slots and holes 12, 13 providedin the second portion 22 of the block then enable guided holes to bedrilled in the sawn end femur surface and for the end of the femur to befurther shaped. The guide slots intersecting the guide holes 13 areinclined with respect to each other and the other two slots in thesecond portion 22 of the guide block are substantially parallel to oneanother. The first portion 21 and second portion 22 of the guide blockare rigidly connected together by a connecting portion 23 which in thisexample is in the form of a relatively thin web 23. The first, secondand connecting portions 21, 22, 23 have in fact been formed by suitablemachining of a single metallic block. The connecting portion 23 can bemade so thin, i.e. having a thickness substantially smaller than thelengths of the guide slots 12 (e.g. between 2-20 mm, 3-12 mm, or even4-6 mm thick), and yet hold the first and second portions 21, 22securely and rigidly together as a result of being formed from a metal,and it will be appreciated that this enables the template system as awhole to provide improved visibility of the bone being worked on to thesurgeon. In other words, as a strong, rigid material can be used for theguide block 21, the connecting portion 23 can be small, and henceobscures only a small part of the bone being worked on.

The locating means body 60 and integral locating fingers 6 in FIGS. 1and 2 may also be described as a customised orienting component, in thatit has been manufactured so as to be patient specific. In contrast, theguide block 2 is not patient specific. Its array of guide apertures 200(i.e. slots 12 and holes 13) are in a predetermined relationship withrespect to each other and are not influenced by the geometry of aspecific patient's bone. Instead, they are arranged so that when used toprepare the surface of a femur, the prepared surface then conforms tothe interior surface of a predetermined prosthesis.

The method by which the template system of FIG. 1 has been manufactured,in addition to taking into account the specific bone shape to determinethe locations, and indeed shapes, of the locator end surfaces 61, 81,has also been arranged to ensure that the positions and orientations ofthe guide slots 12 and holes 13 are such that tools guided by them avoidthe locator body 60, the fixed locators 6 extending from it and the pins7. The removable locator 8 and in particular its tip with end surface81, is, however, in the line of a cut made by the saw guided by slot121. Thus, in use, the removable locator 8 is secured to the locatorbody 60 during the step of positioning the assembled template system onthe femur and remains there until the pins 7 have been driven into thebone to secure the template. The removable locator 8 is then detachedand removed from the locator body 60 before the cut guided by slot 121is made. In this way, cutting of locating means material is avoided.

In certain embodiments, plastic material is used to manufacture thelocating means 1 comprising cannulated locators 6. Suitably sizedmetallic pins 7 may then be received directly in the bores of thosecannulated members 6, i.e. with the pin surface in direct contact withthe plastic interior surface of the bore 62. However, in alternativeembodiments cylindrical sleeves of relatively hard material (e.g. metal)may be provided in these bores 62, with the pins 7 then being receivedinside the sleeves. This can further help prevent contamination of asurgical site with particles of the locating means material, as alllocating means surfaces are kept away from any moving component (pin ortool).

In the embodiment shown in FIG. 1 it will be appreciated that the firstportion 21 of the cutting block 2 is generally curved, and theconnecting web 23 extends generally from a midpoint of the first portion21 to the midpoint of an end surface of the second portion 22 of theblock 2. In other embodiments, however, the web may be connected at adifferent position with respect to the first portion, i.e. notnecessarily at a midpoint. Looking at FIG. 2 , FIG. 2 a shows thetemplate system from FIG. 1 assembled, and arranged in thepredetermined, defined position with respect to the surface of thepatient's femur. Positioning the template against the femur in this wayis part of the process of preparing the bone to receive a selectedprosthesis. The extent would be to drive pins 7 into the bone surfacethrough the bores 62 to secure the template in the illustrated position.Then, a lateral cut would be made by inserting a reciprocating saw bladein the guide slot 201 to remove an end portion of the femur. Theremovable locator 8 could then be detached, and further cuts would thenbe made using the guide slot 12 in the second portion 22 of the block 2and holes would be drilled through guide holes 13.

Although the first portion 21 of the cutting block 2 in FIG. 1 has justone guide slot 210, in alternative embodiments a plurality of adjacentparallel slots may be provided (e.g. two or more, separated byrelatively small distances, such as 0.5-2 mm). These can give thesurgeon a choice and provide some flexibility during surgery as to theposition of a cut. The surgeon can thus adapt to circumstances revealedonly after surgery has begun. The plurality of slots may, of course, beprovided elsewhere on the template block; they are not necessarily on afirst portion.

Referring now to the labelled views of the tibial system in FIGS. 3 & 4, the customised orienting component 101, is located into the top ofstandard cutting block 102 from its underside and firmly attached to itwith a metallic screw 103. Countersunk holes 104 on the under surface ofthe orientating component 101 align precisely with the screw threads 105in the standard cutting block. The customised component 101 has twolocators 106 both of which simultaneously contact the tibial plateau ofthe particular patient, and sit on it in a unique position, thus (alongwith the locators 107 orienting the reusable metallic cutting block inthe appropriate position that has been determined in the preoperativeplanning stage so as to achieve with precision the appropriate bone cutsand alignment of the prosthetic component within the bone.

Although the custom components 101 and 108 are constructed from DuraForm(PA) it is envisaged that they may be constructed from a number ofmaterials that will become available over time.

The customised orientating component 108 is located into protrusions inthe front of the reusable metallic component 102 and firmly attached toit with a metallic screw 109. Countersunk holes 110 on the back surfaceof the orientating component 108 align precisely with the screw threads111 in the reusable metallic cutting block. The custom component 108 hastwo locators 107 both of which simultaneously contact an anteromedialregion of the tibia of the particular patient, and sit on it in a uniqueposition, thus (along with the locators 106) orienting the cutting blockin the appropriate position that has been determined in the preoperativeplanning stage so as to achieve with precision the appropriate bone cutsand alignment of the prosthetic component within the bone.

The orienting blocks are firmly attached to the relevant bone with pinsthrough locators 106 and 107. These are positioned during thepreoperative planning so as to be perpendicular to the bone surface theyare in contact with. This ensures the pins do not skid as they aredriven through the bone surface thus firmly securing the orienting blockin place while the bone is being cut

The ‘tibial’ bone cut is accurately made by passing the saw bladethrough the slit 112 on the cutting block 102. This slit is aligned withprecision to the internal surfaces of the relevant tibial prosthesis.

The reusable metallic cutting block 102 has a hole 113 aligned with theaxis of the tibial component fixation stem and serves to guide withprecision a drill bit through the tibial plateau. Slits 114 in the shapeof a ‘T’ which are aligned to the keels of the relevant tibialprosthesis guide the passage of a saw blade into the tibial plateau withprecision. The resulting hole and cuts in the bone receive the lug andkeel of the prosthesis. For prostheses with different internal surfaceformations, the guide apertures in the cutting block are of courseadapted to facilitate cutting/drilling of an appropriate “receiving”structure on the bone.

Components of the tibial system thus include: Custom component 101;Standard metallic component 102; Metallic screw 103 to fix 101 to 102;Counter sunk hole 104 in custom component 101; Screw thread 105 in 102;Locators 106 associated with 101; Locators 107 associated with 108;Custom component 108; Metallic screw 109 to fix 108 to 102; Counter sunkhole 110 in custom component 108; Screw thread 111 in 102; Slit 112 toguide saw blade; Hole 113 to guide drill; and Slits 114 to guide sawblade.

From the above description of FIGS. 3 and 4 , it will be appreciatedthat these show another surgical template system embodying the inventionand its use in a surgical method to prepare a tibia to receive aprosthesis. The template system of FIGS. 3 and 4 can thus be used inconjunction with template system of FIGS. 1 and 2 in total kneereplacement surgery. It will be appreciated, however, that although thesystem of FIGS. 1 and 2 was described in connection with work on a femurand the system of FIGS. 3 and 4 will be described with reference to workon a tibia, the features of the described systems may also be employedin template systems for working on other bones.

Returning to FIGS. 3 and 4 , in the illustrated embodiment the templatesystem again comprises a metal tool guide block 102 which issteralisable and reusable and is not patient-specific. This metal guideblock (which may also be referred to as a standard cutting block)comprises a first portion 1021, which provides a saw guide slot 112, anda second portion 1022 which provides a guide aperture comprising both aguide hole portion 113 and guide slots 114. A connecting portion 1023 inthe form of a rigid arm or web of uniform thickness connects the firstand second portions 1021, 1022. The first portion 1021 extends around anarc and in this example is curved (i.e. is generally arcuate), providingthe guide slot 112 within which an oscillating saw blade can be movedthrough a defined are to produce a cut on the bone (in this case atibia) being worked on. The connecting arm 1023 is connected to one endof the generally arcuate first portion 1021. As can be seen from thefigures, this arrangement provides the advantage that it gives improvedvisibility of the bone surface being worked on and by reducing theoverall size of the guide block 102 makes the system particularly suitedfor minimally invasive surgery, in that it can be inserted andpositioned on the bone surface through a smaller incision and would benecessary if the first portion of the guide block extended also from theother side of the connecting arm or web 1023. Plus, in contrast to theguide block 2 of the system from FIGS. 1 and 2 which was generallysymmetrical about a plane through the connecting web 23, the guide block102 of this second template system is asymmetric.

In the example shown in FIGS. 3 and 4 , the locating means comprises afirst component 101 (which may be described as a first customisedorienting component) and a second component 108 (which may be describedas a second customised orientating component). The first orientingcomponent 101 comprises a first body portion 1060 and two integrallocators 106 (in this example generally cylindrical locating fingers).These locators 106 extend from the body portion 1060 to their respectiveend surfaces 1061. These locators 106 are again cannulated, havingrespective bores 62 to receive securing pins. The first component 101has been produced by a method involving determining a shape of part ofthe articular surface of tibia, and using the determined shape todetermine the positions and shapes of the end surfaces 1061 of thelocators 106 such that they help seat the assembled template system onthe specific tibia in a well defined position. The second portion of theguide block 1022 is adapted to receive the body portion 1060 of thefirst component 101 from below, such that the guide block then preventsany further upwards movement of the component 101. When assembled inthis manner, a screw or bolt 103 is inserted through a hole 104 in thefirst component 101 and is received in a threaded hole 1030 in thesecond portion of 1022 of the guide block 102. This screw 103 is thentightened to releasably and non-adjustably attach the first component101 to the guide block so that its locating surfaces 1061 are in fixedposition with respect to the plurality of tool guiding apertures.

Similarly, the second customised locating component 108 comprises a bodyportion 1060 from which two locating fingers 107 extend to theirrespective bone-engaging surfaces 1071. Again, this second locatingcomponent 101 has been produced by a method involving determination of ashape of the tibia surface and rapid prototyping to produce thecomponent 108 such that the end surfaces 1071 conform to and are seatedon non-articular portions of the tibia surface when the template systemis in the desired, defined position. The second component 108 is adaptedto slot into the nominal base of the first portion 1021 of the cuttingblock and is then secured and attached in this assembled position bymeans of another screw or bolt 109 passing through a hole 110 into athreaded hole 111 in the first portion 1021 of the guide block 102.

Referring in particular to FIG. 4 , these views show the assembledtemplate system of FIG. 3 arranged in the predetermined, defined (andsubstantially unique) position on a tibia, with the locators 106engaging portions of the articular surface of the tibia, and the endsurfaces 1071 of the other locators 107 engaging portions of thenon-articular surface of the tibia. As can be seen from the figures, thefirst portion 1021 of the cutting block extends around less than aquarter of the circumference of the tibia when looking generally alongthe longitudinal axis of the tibia, and in FIG. 4 c ). However, thecurved guide slot 112 it provides enables a saw blade guided by thatslot to reach the entire tibia surface. Plus, the arrangement isparticularly suited to minimally invasive techniques. Although not shownin FIG. 4 , with the template arranged in the shown position, pins willthen be driven through the bores 62 to secure the assembled templatesystem to the bone. The slot 112 can then be used to guide a saw bladeto produce a cut across the end of the tibia. The composite guideaperture (comprising guide hole 113 and slot 114) in the second portionof 1022 of the guide block can also be used to cut a correspondinglyshaped recess in the end surface of the tibia to receive acorrespondingly shaped formation (which may also be referred to as akeel) on an underside of a tibial prosthesis for fitting to the preparedbone.

Again, the two-part locating means 101, 108 of the template system inFIGS. 3 and 4 has been manufactured according to a determined shape ofthe bone to be worked on and such that the locating means is avoided bytools guided by the plurality of guide apertures in the reusable guideblock 102. By doing this, small particles of locating means material arenot produced when working on the bone and hence contamination of thesurgical site by such particles is also avoided.

Referring now to FIG. 5 , this shows views of surgical apparatus inaccordance with another aspect of the present invention. As mentionedabove, the two template systems of FIGS. 1-4 can be used in total kneereplacement surgery for fitting prostheses to both the femur and tibia.Those template systems comprise reusable metal cutting blocks and aplurality of patient-specific custom-made components forming thelocating means. The apparatus of FIG. 5 comprises the plurality ofcomponents of the custom-made locating means for the femoral and tibialtemplate systems corresponding to a particular patient's knee joint,together with patient identification means, providing an indication ofthe particular patient to whom the knee belongs, and linking meanslinking the locating means to the patient identification means. In thisexample the linking means is in the form of a rod 201, which passesthrough holes in each of the individual components of the locating meansof the femoral and tibial template systems and connecting them to anidentification plate 202 which carries information 2020 identifying thepatient. Both ends of the rod 201 are connected to the plate 202 so thatthe locating means components cannot become separated from it. Asfurther security, the plate 202 carries a unique identifier 9 and eachcomponent of the locating means also carry this identifier. Thus, thesurgical apparatus, which can also be regarded as a pack ofpatient-specific components, can be provided to the surgeon. A linkingmeans (rod 201) can then be broken or cut to separate the locatorcomponents, which can then be assembled together with the sterilised,reusable cutting blocks.

Thus, FIG. 5 shows surgical apparatus embodying the invention andcomprising customised components, immediately after manufacturing. Thecustomised orientating components 1, 8, 101 and 108 have beenmanufactured with rapid prototyping technology, threaded together as agroup, with an additional thin elongate rod 201 that is attached at bothof its ends to a plate 202 containing a unique identification string ofalphanumeric characters for each patient. Each component within thegroup will have inscribed on it means of identification as belonging tothis group. This mode of manufacturing is adopted to prevent mixingcomponents manufactured for different patients. The apparatus (which canbe described as a custom part holder) thus includes: Custom femoral part1; Custom removable locator 8 for femoral part; Unique code 9 whichcorresponds exactly to the code given by 202; 101 Custom tibial part fortibial plateau; Custom tibial part 108 for anteromedial tibia; Elongatedrod 201; and plate 202 carrying unique identification string ofalphanumeric characters for each patient

Certain embodiments of the invention are modified so as to facilitateachieving bone cuts in TKR surgery that adopts a minimally invasive (MI)approach. In this approach it is aimed to perform the bone cuts andimplantation procedure through the smallest possible incision into thejoint. This reduces the trauma to the surrounding tissues, and speeds upthe recovery of the patient.

In certain examples of MI surgery two different template systemsembodying the invention are used, one for use with the femur the otherwith the tibia, to aid the surgeon in cutting the knee bone. Eachassembly comprises a patient specific orienting block(s) and twoseparate cutting blocks with the appropriate number of slits and holesguiding moving surgical tools to make the cuts in the relevant boneaccurately and correctly oriented so as to receive the relevantprosthetic component in the position determined by the preoperativeplanning procedure. The orienting and cutting blocks are assembled andfirmly attached with screws to form a rigid unitary guide that locatesin a unique position onto the relevant bone and is pinned to the bone ata number of carefully chosen sites on the bone such that the pins avoidthe path of the saw blade used for making the bone cuts. Using theresults of the first cutting block a second cutting block is then guidedinto position and the preparation of each bone completed so as toreceive the relevant prosthetic component.

Detailed views of the minimally invasive femoral and tibial assembliesembodying the invention are given in FIGS. 6-9 .

FIG. 6 illustrates exploded views of Part A of the femoral device fromthe front, top, bottom, and side, along with an isometric view. FIG. 7illustrates views of the same device assembled and pinned to the femur.FIG. 8 illustrates exploded views of Part B of the femoral device fromthe front, top, bottom, along with an isometric view. FIG. 9 illustratesviews of the same device pinned to the femur after the distal cut hasbeen made.

Referring to the labelled views of the MI femoral system in FIGS. 6 & 7, the customised orienting component 301, is located into a protrusionin the reusable metallic cutting block 302 and firmly attaches to itwith a metallic screw 303. Countersunk holes 304 on the upper surface ofthe orientating component align precisely with screw threads 305 in thestandard cutting block.

Although the custom component 301 is constructed from DuraForm (PA) itis envisaged that it may be constructed from a number of materials thatwill become available over time. The customised component includes threelocators 306 all of which simultaneously contact the bone of theparticular patient, and sit on it in a unique position, thus orientingthe cutting block in the appropriate position that has been determinedin the preoperative planning stage so as to achieve with precision theappropriate bone cuts and alignment of the prosthetic component withinthe bone. In addition to the three locators the customised componentalso has a protrusion 307 which also sits on the bone of the particularpatient in a unique position, thus also assisting in the orientation ofthe cutting block. It may be appropriate to vary the size of thisprotrusion. An alternate approach is this protrusion as a guide, which,although close to the bone surface of the particular patient it will notcome into contact with it.

The orienting block is firmly attached to the relevant bone with pins308 through locators 306. These are positioned during the preoperativeplanning so as to be perpendicular to the bone surface they are incontact with. This ensures the pins 308 do not skid as they are driventhrough the bone surface thus firmly securing the orienting block inplace while the bone is being cut. The locator 306 a sits in thetrochlea of the femur and so acts as an additional reference with regardto placement of the device.

The distal bone cut is accurately made by passing the saw blade throughslit 309. This slit is aligned with precision to the internal distalsurface of the relevant femoral prosthesis. The size of both the slit309 and the standard cutting block. 302 is determined prior tomanufacturing based upon the thickness of saw blade to be used and thepermitted deviation of the saw blade in the slit 309. The standardcutting block 302 has two holes 310 to guide a drill bit into both themedial and the lateral condyles of the femur. The resulting holes in thebone ultimately receive the fixation lugs of the prosthesis.

The resulting flat bone surface created by performing the distal cutalong with the holes in the medial and lateral condyle are also used tolocate Part B of the femoral device.

Referring now to part B of the MI femoral template system, the lugs 311are located in the drilled holes in the medial and lateral condyles andthe flat surface 312 of the cutting block 313 placed precisely onto thecut flat surface created by performing the distal cut. The flat surface312 is aligned with precision to the internal distal surface of therelevant femoral prosthesis. The cutting block 313 is securely fastenedto the flat bone surface by pins 314. These pins pass through lugs 315which each have a hole of precise dimensions to guide the pin into thebone whilst avoiding both the lugs 311 and the saw blade.

In order to prevent the pins 314 from loosening by vibration during thebone cutting procedure a means of locking the pins into lugs 315 isprovided. Such means (not shown) would by the way of example be a springwasher to be fitted in a groove in the pin 314 which would come intoview, once the pin has been driven into the bone, at the side of the lug315 nearer to the bone.

The four slits 319 are aligned with precision to the remaining fourinternal surfaces of the relevant femoral prosthesis. The size of boththe slits 319 and the standard cutting block 313 is determined prior tomanufacturing based upon the thickness of saw blade to be used and thepermitted deviation of the saw blade in the slits 319.

From the above description of FIGS. 6-9 it will be appreciated that theillustrated surgical template system comprises a first tool guide block,patient-specific locating means 301, attachment means 303 for releasablyand non-adjustably attaching the locating means 301 to the tool guideblock 302, and a second tool guide block 313 having a flat surface 312adapted to sit on a bone flat surface prepared using the first toolguide block 302. The first tool guide block 302 again comprises a firstportion 3021 to which the locating means 301 is securely fastened (i.e.clamped) by the attachment bolt 303. This locating means 301 againcomprises a body portion 3060 and three integrally formed locatingfingers 306. In addition, the locating means includes an additionalintegral locator 307 in the form of a protrusion extending from the body3060. The three locating fingers 306 are cannulated, whereas theadditional locating protrusion 307 is solid. The locating means 301 isarranged to key with the guide block 302 and to this end the locatingmeans body 3060 is provided with a pair of slots or mortises 3065adapted to receive correspondingly shaped tongues or tenons 3056 on thefirst portion 3021 of the guide block. This first portion 3021 of theguide block provides a tool guiding slot 309 which is open at both endsof the first portion 3021. This facilitates insertion of a saw blade 15into the slot. Furthermore, by not requiring material to close the slotat both ends, it enables the size of this first portion 3021 to be madesmaller than would otherwise be the case and so makes the templatesystem more suitable for minimally evasive surgery. The first guideblock 302 again comprises a connecting portion 3023 in the form of a webor connecting arm, connecting the first portion 3021 to the secondportion 3022 which in this example comprises a pair of guide holes 310.Again, the first guide block 302 is asymmetrical, with the connectingweb 3023 being connected to the first portion 3021 towards one end ofthe open ended guide slot 309. In use, the assembled first guide block302 and customised locator component 301 are positioned against thefemur as shown in FIG. 7 , and pins 308 are driven through the bores 62in the cylindrical locators 306 to attach the template to the bone. Thesaw blade is then inserted in guide slot 309 and appropriatelymanipulated to cut a flat end surface of the femur. Then, guide holes310 are used to guide a drill to drill two locating holes in the sawnend surface of the femur. The assembly is then detached from the femurand the second guide block 313 is then positioned on the sawn femursurface, with its flat surface 312 in contact with the sawn surface ofthe bone and with locating protrusions 311 located in the locating holespreviously drilled-using guide apertures 310. The second guide block 313is then secured in place and the guide slots 319 are used to guide thesaw blade to perform further work on the femur.

It will be appreciated that the first and second guide blocks 302 and313 of the template system showing FIGS. 6-9 are individually smallerthan a guide block that would be required if that guide block were toprovide all of the guide apertures to prepare the femur surface in themanner shown. Thus, by effectively splitting the guide block into two,with each component being relatively small, the template system of FIG.6-9 is particularly suited for minimally invasive surgery.

A minimally invasive two-part tibial template system embodying theinvention will now be described. Referring to the labelled views inFIGS. 10 & 11 , the customised orientating block 401 is located onto thestandard cutting block 402 with protrusions in the latter. Metallicscrews pass through countersunk holes 403 on the upper surface of theorientating component 401 and fasten with precisely aligned screwthreads 404 in the standard cutting block 402. The customisedorientating component 405 is located into the front of the standardcomponent 402 with protrusions in the latter and firmly attached to itwith a metallic screw. Countersunk holes on the back surface of theorientating component align precisely with the screw threads in thestandard cutting block. In doing so the customised orientating blocksand the standard cutting block are firmly fixed together.

The customized orientating block 401 has protrusions 406 and thecustomized orientating block 405 has locating cylinders 407 all of whichsimultaneously contact the bone of the particular patient and sit on itin a unique position thus orientating the cutting block in theappropriate position which is determined during the preoperativeplanning stage so as to achieve with precision the appropriate bone cutsand alignment of the appropriate prosthesis within the bone.

The orienting block is firmly attached to the relevant bone (see FIG. 11) with pins 408 through locators 407. These are positioned during thepreoperative planning so as to be perpendicular to the bone surface theyare in contact with. This ensures the pins 408 do not skid as they aredriven through the bone surface thus firmly securing the orienting blockin place while the bone is being cut. Attention is paid to the positionof the pins relative to one another during the preoperative planningprocedure to ensure they do not collide with one another when driveninto the bone. The tibial bone cut is made by passing a saw bladethrough slit 409. This slit can be open at either end so as to allowgreater movement of the saw blade whilst making the tibial cut.

With regard to the second part (part B), referring to the labelled viewsin FIGS. 10 & 12 , after making the tibial cut the waste bone is removedand the standard cutting block 410 is positioned onto the cut bonesurface 411. This cutting block has an arm 412 with a rectangularsection 413 of precise dimensions removed from it. This allows thecutting block 410 to be guided into the position determined during thepreoperative planning procedure by the rectangular post 414 which hasprecise dimensions and forms part of the cutting block 402. The cuttingblock 410 is then pinned to the bone through holes 415. These may beinclined slightly so as to offer a more secure placement of the block410. It may be necessary to remove one or more of the pins 408 so thattools can be passed through the guide 416 and into the bone unhinderedas the tibia is prepared to receive the appropriately sized prosthesis.

From the above description of FIGS. 10-12 it will be appreciated thatthe template system again comprises a first tool guide block 402 and asecond tool guide block 410. Also, in that system the locating meanscomprises a first body portion 4060 and a plurality of locating fingers407 formed integrally with the body portion 4060 and extending from itto respective bone engaging end surfaces 4071. Attachment means in theform of a screw (not shown in the figure) can be used to attach thefirst body portion 4060 to the first guide block 402. The locating meansalso comprises an additional body portion 4066. A pair of additionallocating members 406 in a form of fifths is integrally formed with thesecond body portion 4066, and extend from it to their respective endsurfaces 4061 which have been manufactured to conform with and engagerespective portions of the surface of a bone to be worked on. Theattachment means comprises additional screws or bolts to attach theadditional body portion 4066 to the first guide block 402 by means ofholes 403 in the additional body portion and threaded holes in the firstguide block 402.

The first guide block 402 comprises mounting means in the form ofmounting post 414 for mounting the second guide block 410 on the firstguide block 402 after the first guide block and locating means assemblyhas been used to guide a saw, using guide slot 409 to produce a cutsurface on the end of the tibia. When the second guide block 410 hasbeen mounted in place of first guide block the second guide block 410can be used to guide a drill and then a saw blade using composite guideaperture 113, 114. Again, by employing a template comprising twoseparate guide blocks, the individual guide blocks can be made smallerthan would be the case of a single guide block providing all guideapertures were used, and hence the system is particularly suited tominimally invasive surgery.

Another two-part minimally invasive tibial template system embodying theinvention will now be described with reference to FIGS. 13 to 16 .Referring to the labelled views in FIGS. 13 & 14 , the customisedorientating block 501 is located onto the standard cutting block 502with protrusions in the latter. Metallic screws pass through countersunkholes 503 on the upper surface of the orientating component 501 andfasten through precisely aligned screw threads 504 in the standardcutting block 502. The customized orientating component 505 is locatedinto the front of the standard component 502 with protrusions in thelatter and firmly attached to it with a metallic screw. Countersunkholes on the back surface of the orientating component align preciselywith the screw threads in the standard cutting block. In doing so thecustomised orientating blocks and the standard cutting block are firmlyfixed together.

The customized orientating block 501 has protrusions 506 and thecustomized orientating block 505 has locating cylinders 507 all of whichsimultaneously contact the bone of the particular patient and sit on itin a unique position thus orientating the cutting block in theappropriate position which is determined during the preoperativeplanning stage so as to achieve with precision the appropriate bone cutsand alignment of the appropriate prosthesis within the bone.

The orienting block is firmly attached to the relevant bone (see FIG. 14) with pins 508 through locators 507. These are positioned during thepreoperative planning so as to be perpendicular to the bone surface theyare in contact with. This ensures the pins 508 do not skid as they aredriven through the bone surface thus firmly securing the orienting blocin place while the bone is being cut. Attention is paid to the positionof the pins relative to one another during the preoperative planningprocedure to ensure they do not collide with one another when driveninto the bone. The tibial bone cut is made by passing a saw bladethrough slit 509. This slit can be open at either end so as to allowgreater movement of the saw blade whilst making the tibial cut.

Referring to the labelled views in FIGS. 15 & 16 , after making thetibial cut the waste bone is removed, along with Part A of the tibialdevice. The customized orientating block 509 is located onto the arm 510of the standard cutting block 511 and may be firmly attached to it bymeans of a metallic screw. The standard cutting block 511 is positionedonto the cut bone surface 512. Locating cylinders 513 all of which aresectioned along their long axis simultaneously contact the bone of theparticular patient and sit on it in a unique position thus orientatingthe cutting block 511 in the appropriate position which is determinedduring the preoperative planning stage so as to achieve with precisionthe appropriate bone cuts and alignment of the appropriate prosthesiswithin the bone. These sectioned cylinders align precisely with thecylinders 507 from Part A of the tibial device. Thus after removing PartA the pins 508 may be replaced and the sectioned cylinders 513 locatedupon them so as to increase the accuracy of placement.

The cutting block 511 is then pinned to the bone through holes 514.These may be inclined slightly so as to offer a more secure placement ofthe block 511. It may be necessary to remove one or more of the pins 508so that tools can be passed through the guide 515 and into the boneunhindered as the tibia is prepared to receive the appropriately sizedprosthesis.

It will be appreciated from the above description of FIGS. 13-16 thatthe template system comprises a first guide block, providing a single,open ended guide slot 509, and locating means comprising a first bodyportion 5060 from which a plurality of locating members 507 extend, anda second body portion 5036, from which a further plurality of locatingmembers 5061 extend. The attached assembly of the first guide block 502and first locating means 501, 505 is positioned on the bone surface,secured in place using pins through the locators 507, and the guide slot509 is used to guide a saw to produce a cut in the tibia end surface.The assembly is then removed from the tibia. The template systemcomprises a separate, second tool guide block 511 and a separate, secondlocating means 509 which comprises an integral body and plurality oflocating fingers 513. This second locating means 509 is adapted toreceive the second guide block 511 and holds that second guide block inthe desired, correct position on the tibial sawn surface when the secondlocating means 509 is pinned in place.

Manufacturing methods, surgical methods, and methods of fittingprostheses embodying the invention will now be described.

With regard to the application of this invention in the field of totalknee replacement (TKR) surgery a number of steps need to be followedwhich are unique to the device itself. These are summarised in theflowcharts in FIG. 17 . FIG. 18-20 identify the decisions and processesinvolved in Steps B-D which are discussed in more detail below. FIG. 21illustrates a view of the femur from below along with isometric views ofthe femur, femoral prosthesis, femur with all bone cuts performed andthe prosthetic component aligned to the cut femoral bone. FIG. 22illustrates a view of the tibia from above along with similar isometricviews of the tibia.

Step A—Imaging

Images of the patient's joint under consideration may be acquired usingCT, MRI or any other appropriate imaging modality. These are used togenerate 2D/3D digital models of the joint bones from which it ispossible to make accurate anatomical measurements, which will determinethe size of prosthetic components for the recipient. These 2D/3D modelswill also allow accurate placement of virtual prosthetic components andtheir corresponding templates.

Step B—Preoperative Planning

Overview

Proper treatment planning is essential for the long-term success of thesurgical procedure.

Reconstruction of the CT data (for example) provides 3-D images, of thefemur and tibia, without details of the surrounding soft tissues (StepA). Determining the correct size of the prosthetic femoral component canbe achieved by measuring the antero-posterior (AP) dimension AP_(fem) ofthe distal femur (FIG. 21 ). Similarly measurements of the widthWIDTH_(tib) and antero-posterior AP_(tib) dimensions of the proximaltibia (FIG. 22 ) will determine the appropriate size of the prosthetictibial component. From these measurements selection can be made of theexact (or a closely matched) size of prosthetic component for therelevant bone (FIG. 21 c and FIG. 22 c ), from the electronic library ofprosthetic components' files containing their exact geometries anddimensions. Sizing accuracy is confirmed when the selected component issuperimposed (i.e. virtually implanted) over the bone and observed onthe 3-D models or the 2-D projections obtained from the CT data. Forinstance the correct size when placed optimally will avoid violating theanterior cortex of the femur and exclude overhanging of the tibialcomponent beyond the tibial bone. The interactive 3-D manipulation ofimages allows adjustment of rotation, translation, and inclination ofthe prosthetic components until the optimum alignment of the prosthesiswithin the joint is achieved. Thus in place (FIG. 21 e and FIG. 22 e ),the final shape of the bone (FIG. 21 d and FIG. 22 d ) after all thecuts are made is defined by the prosthesis internal surfaces (these willbe in direct contact with the bone). The position of the metallicreusable cutting block referred to earlier is then aligned so that itsslits and guide holes coincide with the planes defining the final shapeof the bone (these are the planes defining the internal surface of theprosthesis). The design of the single use component (the standard partof which will be already attached to the reusable metallic block) isthen finalised by adjusting the positions and orientations of itslocators so that these are perpendicular to the surfaces of the bonewhere they come into contact with it. Once the locators are positionedthe single use component is ready for manufacturing using rapidprototyping technologies.

Step B₁—Anatomical Measurements:

Anatomical measurements are taken using the images acquired in Step A.These are used to help select the most appropriately sized prostheticcomponents for a given patient. The decision at this stage is notcritical as it is possible to try simultaneously a range of prostheticcomponents of different sizes on the relevant bone, as described in StepB₂ and finalise the decision on selecting the best size in step B₃.

Step B₂—Importing of Standard Prosthesis & Template Library:

As will be appreciated, the assembly of the guide for a given prostheticsize is the same except that the locators of the customised componentsare the only aspect that needs to be adjusted (customised) for therecipient. It is possible to construct a library of electronicassemblies, each pertaining to one of the different sizes of theprosthetic components. Such an electronic assembly would comprise thevirtual prosthetic component aligned to the assembled guide componentsfor that prosthetic size such that the slits and holes guiding thecutting instruments coincide with the inner surfaces of the prostheticimplant and fixation lugs.

Step B₃—Sizing of the prosthetic Components and determining theirOrientation in the joint

When the electronic assembly is imported on the screen and oriented withrespect to the relevant bone such that the prosthetic component isoptimally placed on the bone (as described above), the standard assemblyof the guide is automatically placed in the correct orientation so thatthe bone cuts made during surgery would be identical to that in thepreoperative planning procedure. Only the locators' positions on thesingle use component, their lengths and orientations with respect to thebone remain to be finalised in Step B₄.

If the prosthetic size first determined from the anatomical measurements(Step B₁) is slightly larger or slightly smaller, a prosthesis of adifferent size together with its guide assembly could be imported andused instead. However, to save time it is proposed to import all theelectronic files of these assemblies of prosthetic components andassociated guide assemblies simultaneously and once the correct size hasbeen identified all the others can be discarded.

Step B₄—Customised Elements Design

Whilst positioning the customisable parts it is vital to superimposeimages which highlight the paths of the saw blade, drill bits and pins(used to firmly attach the guide to the bone while it is being cut) soas to avoid any obstructions by these during the preparation of thebone. Each locator therefore has a locus of points 320 relative to eachtemplate within which it must be placed. Each locus can be representedvisually and therefore forms an integral part of the template library.It is anticipated that the locus of each locator can be used to fullyautomate Step B₄.

The locus of points for each locator has to be of sufficient size so asto account for the variability of the anatomy between patients. This isachieved by ensuring each custom part can accommodate the locators in anumber of positions. For example with the custom part 301 the locators306 can be united with a number of different locator arms 321. Byuniting the locators 306 with single arms 322 the visibility the surgeonhas of the joint whilst performing the bone cuts is kept to a maximum.

After the optimal position for each locator has been decided and fixed anumber of Boolean operations are performed on the template. These areused (i) to unify the customizable components of the relevant templateso that a single part is formed which can then be fixed to the relevantstandard metallic component, and (ii) to ensure the custom parts matchwith precision the bone surface upon which they will eventually sit.

Step C—Manufacturing

Step C₂—Manufacture Reusable Standard Parts by CNC Machining or RapidPrototyping

Reusable standard parts are manufactured by CNC machining or rapidprototyping.

Step C₂—Manufacture Custom Parts by Rapid Prototyping

The custom parts for a given patient are manufactured together asseparate parts held together by a rod using rapid prototyping. Althougheach part is free to move on the rod it cannot be removed unless the rodis broken. Each part has a unique identifier which corresponds to thepatient for which they are intended.

Step C₃—Clean and Assemble Custom Parts

The custom parts are removed from the rod and cleaned prior toassembling them on their corresponding standard metallic parts.

Step C₄—Sterilisation of Devices

The assembled components are sterilized and packaged ready for shipping.

Step D—Surgery

Step D₁—Assembled Device Fitted to Patient

The assembled device is fitted to the patient so as to conform to theunique position relative the 30 patient's anatomy as identified in StepB.

Step D₂—Procedure Performed

The template is used to guide the necessary bone cutting for therelevant prosthesis to be received.

As will be appreciated, certain embodiments of the invention providetemplate systems for knee surgery. The knee joint comprises two cruciateligaments: the anterior cruciate ligament and the posterior cruciateligament. The anterior cruciate ligament is not ordinarily preservedduring total knee replacement surgery; indeed very few of the prior arttotal knee replacement systems allow the preservation of this ligamentafter surgery. However, using embodiments of the present invention itmay be possible to preserve the posterior cruciate ligament during totalknee replacement surgery, and in many cases this is desirable. Thesurgeon is able to make this decision whilst in the operating theatreand no additional instruments are required to ensure its preservation.Certain minimally invasive tibial template systems embodying theinvention avoid the tibial plateau; they can be located on theappropriate bone whilst avoiding damage to the cruciate ligament.Similarly, the femoral template system can be placed on the femurwithout the need to cut the cruciate ligaments. Additionally, to aidaccurate template placement the locators of certain template systemsembodying the invention have minimal contact between the bone andthemselves. The contact surfaces used in the prior art have to be largebecause of the local geometry of the bones upon which they sit, reducingthe surface area that contacts the bone may significantly reduce theiraccuracy. Adapting the templates described in the prior art forunicondylar knee surgery appears not to be possible.

Unicondylar knee arthroplasty is minimally invasive and requires bothcruciate ligaments to be preserved. Therefore embodiments of the presentinvention can be used to achieve this: the unicondylar templates wouldbe very similar to the minimally invasive femoral and tibial templatesdescribed above, in all respects but size: they would be smaller. Theadoption of CAS in unicondylar knee replacement allows placement of thefemoral component such that the surface of the implant merges with thatof the femoral condyle to form a smooth contour. This is very difficultto achieve with conventional instrumentation and the result is that theimplant either protrudes above or locates below the surface of thecondyle forming a step onto which the patella comes into contact with.This is undesirable as it might cause wear of the patella and mightcause pain to the patient. Embodiments of the invention are able tosolve this problem.

Referring now to FIGS. 24 to 27 , these show tibial template systemsembodying the invention and incorporating removable locators. In FIG. 24the removable locator 91 is shown sitting is shown in the intendedposition. The locator helps the surgeon correctly position the deviceprior to fixing it upon the bone. It need not be removed as it ispossible to include a slit 92 during its manufacture which allowsunhindered movement of the saw blade during the preparation of the bonefor the prosthesis. There is a hole 93 in the removable locator 91. Thishole is aligned precisely to a hole which passes through the arm 94 ofthe standard tibial device. This allows a removable metal pin to bepassed through 93 and into the standard metallic component. This pinalong with the metal lug 95 of the standard tibial device locks thelocator into position. The lug 95 is so designed that once the pin isremoved the locator 91 can be removed without dislodging the fixeddevice.

FIG. 25 shows a tibial device similar to that shown in FIG. 1 . Howeverthe removable locator 96 is inside the arm 97 of the standard part 98.This reduces the size of the device in FIG. 25 compared to that in FIG.24 . FIG. 26 shows the same standard metallic part 97 as that shown inFIG. 25 but with the removable locator 96 no longer in place. The metallug 99 holds the removable locator in position along with a metal pinsimilar in nature to the pin described above.

FIG. 27 shows the same tibial device as FIG. 24 . The custom part 910 islocated into the metallic part 911 and the two parts secured with a boltor screw. Attention has to be paid to the tolerances of each partotherwise they will not fit together. Where there is a curved regiongaps 912 exist between the custom part 910 and the metallic part 911. Byreducing the area of contact between 910 and 911 in the verticaldirection to two orthogonal regions 913 and 914 the preciseness of fitbetween 910 and 911 is maintained whilst the risk of the custom part 910being too large for the standard part 911 is reduced.

In certain embodiments the orienting block 1 (or locating means) isfirmly attached to the relevant bone with pins through locators 6. Theseare positioned during the preoperative planning so as to beperpendicular to the bone surface they are in contact with. This ensuresthe pins do not skid as they are driven through the bone surface thusfirmly securing the orienting block in place while the bone is beingcut. However there are instances when it may be advantageous to fix boththe orientating block and its standard cutting block (tool guide block2) to the relevant bone with pins. Such an example is shown in FIGS. 28and 29 . In certain alternative embodiments, just the tool guide blockmay be attached to the bone. To enable the tool guide block to beattached to the bone it is provided, in certain embodiments, with one ormore bores (which may also be described as pin holes or guides). Thus,in certain embodiments, the system comprises pin holes passing through ametallic cutting block.

The example shown in FIGS. 28-29 is that of a femoral template, but themajority of features that will be described in detail are alsoapplicable in principle to the tibial template and indeed any othertemplate system for use on a bone. An asymmetrical custom part (in thisinstance) [a_1] (or locating means 1) is firmly attached to a standard,re-usable cutting block [a_2] (or tool guide block 2). The arms [a_7] ofthe locating means are therefore close to the appropriate bone, soreducing the intra-operative displacement of a number of tissues whilstincreasing the strength of the custom part. The customised part [a_1] isguided into the correct position (for attachment to the cutting block)by pegs [a_37] (see FIG. 29 ) on the under surface of the locating means[a_1]. These pegs sit in holes [a_38] that originate on the uppersurface of the guide block [a_2]. Once in position, the custom part[a_1] is firmly and securely attached to the standard cutting block[a_2] by means of a hexagonal fixing bolt [a_9] in this example(alternative embodiments may of course employ alternative attachmentsmeans. The pegs [a_37] may be positioned in a manner that ensures thecustomised parts can only be secured to the correct sized cutting block[a_2] as determined by the preoperative plan.

The standard cutting block [a_2] is located on the bone as determined bythe orientating block (custom part) [a_1]. The locating fingers [a_8](which may also be described as locators 6) of the orientating blocksimultaneously contact the bone of the particular patient and sit on itin a unique position, thus orientating the cutting block in theappropriate position. Once this unique position has been achieved it canbe fixed securely in place with a number of pins. Two of the pins [a_3]pass through the standard block in this example (in other words, theypass through bores [a_12] in the tool guide block. These pins areparallel to one another and the slit [a_10]. The pins [a_3] are almostperpendicular to the anterior bone surface. In this instance slit [a_10]allows the distal bone cut to be made by accurately guiding the sawblade. By having the pins [a_3] parallel to one another it is possibleto remove the template whilst keeping the pins [a_3] in situ (providedor course that any other pins that would otherwise prevent this removalhave been removed or are not yet fitted, or the locating means has beendetached from the tool guide block). Thus, the tool guide block may beseparated from the bone by sliding it off the parallel fixing pins. Thisallows additional parts to be readily fitted to the standard part [a_2]or, the custom part [a_1] intra-operatively without the potential forinterference from the patients surgically exposed tissues.

In FIG. 29 the holes [a_12] that allow the passage of pins [a_3] areshown. Although only two holes are shown it is possible to have a seriesof holes whose axes are all parallel to one another; the two mostconvenient holes may be then selected by the surgeon intra-operatively.By having the holes [a_12] in the standard metal part it is possible todrill the pins into place without the danger associated with theshedding of material into the patient's tissues. Pin [a_4] passesthrough the custom part [a_1]. This is guided by the bore [a_5] (througha locator [a_8]) whose orientation is adjusted pre-operatively so thatits orientation is perpendicular to the surface of the patient's bone(to prevent skidding as it is driven into the bone). Pin [a_4] isapproximately perpendicular to the pins [a_3], so it serves to ‘lock thetemplate’ in place. The surgeon has greater access to the patient's kneebones from the medial side hence the bore [a_5] is located on the medialside of the operated joint.

Although only one pin [a_4] is shown through bore [a_5], additional,similar pins and bores that pass through the custom part [a_1] may berequired to fix the template firmly in place and prevent it fromloosening as the bone is cut with the oscillating blade. These pins andbores may be in positions that are anterior or lateral to the patient'sknee bone. It is also feasible for the standard part [a_2] to bemodified so that a pin serving the same function as [a_4] passes throughthe standard part in addition to, or instead of, those passing throughthe custom part. Any pin passing through the standard part may be drivenor drilled into the bone without the danger of shedding particulatematerial into the patient's bone.

Achieving placement of a customised template component on its respectivebone requires careful consideration of the number and positions of thelocators. The following applies to the component customised for thefemoral bone. The customised template component might have five locators(for example), two on the medial side, one anterior and two on thelateral as illustrated in FIG. 28 . While the template component mightbe placed such that the five locators are simultaneously in contact withthe bone there is still the possibility that the template can beincorrectly placed: because of the presence of a slippery soft tissuelayer (albeit thin) on the bone surfaces, this renders the contactbetween the locators and bone surfaces to be soft and consequently thetemplate may easily be pushed further in an inferior direction thusresulting in inaccuracies in cutting the bone. For this reason, inanother template system embodying the invention, an additional locatoris included and which is arranged to limit movement of the template inthe direction mentioned above.

In certain examples, this additional locator is a removable locator[a_13], and is shown in FIG. 28 and FIG. 30 . This sits inferiorly tothe patient's femoral condyles and simultaneously contacts the patient'sknee bone along with the locating fingers [a_8]. To ensure all of thelocators contact the bone simultaneously the surgeon may have to removesome cartilage from the surface of the condyles. The removable locatoris locked into the standard part [a_2] within of the bore [a_14] andconstrained by the arms [a_15]. To fit the removable locator its shaft[a_130] is inserted into bore [a_14] from below, and twisted such thatthe arms [a_15] capture its lugs [a_150]. It may be necessary to includea series of bores similar to [a_14] or a slit within the standard partso that the most suitable position for the removable locator can bedetermined during the pre-operative planning stage. The inclusion ofappropriate lettering [a_16] (A for anterior, a P for posterior in thisinstance) or symbols ensures the removable locator is correctlyorientated with the standard part.

The slit [a_10] extends laterally and medially (see FIG. 28 ) but isclosed centrally so that the sawblade can make the intended bone cutthough it (see FIG. 31 ). The central solid section within the said slitallows the thread of the hexagonal fixing bolt [a_9] to pass through thebody of the standard part. The central portion [a_17] is angled topermit a greater range of movement for the saw blade.

Implants of the same type are available in a number of different sizes.The most appropriate implant size for the patient is determined fromappropriate measurements taken from the patient's bones preoperatively.Different implant sizes may require standard cutting blocks such as[a_2] shown in FIG. 28 to be of different sizes. Thus implants of thesame type may require an inventory of a plurality of cuttings blocks(e.g. six), each a different size but all similar to [a_2]. The correctsize of cutting block for a given patient is determined during thepreoperative plan. However, by allowing the relative positions of thedistal cut block and the lug block to be changed it may be possible toreduce the number of standard blocks [a_2] required (typically from 6 to2) for a given implant type.

FIG. 32 shows a standard cutting block comprising of two main parts (inthis instance) [a_18] and [a_19]. The position of [a_18] relative to[a_19] may be adjusted and fixed rigidly with a screw or screws (forexample) such as that shown [a_21] according to the size of implantrequired. The screw locates in depressions [a_22] on the arm [a_23]. Acustom part similar to [a_1] (shown in FIG. 28 and FIG. 29 ) is securelyfastened to the distal cut block [a_18] and serves to orientate both thedistal cut block and the lug block [a_19] simultaneously according tothe preoperative plan. The lug block [a_19] has two holes [a_20] passingthrough it. The purpose of the holes [a_20] in both FIG. 29 and FIG. 32is to guide a drill in preparing holes that will allow a cutting blocksimilar to the one shown in FIG. 8 to be positioned on the bone asindicated in FIG. 9 . These holes align exactly with the lugs [311] asshown in FIG. 8 . They may also coincide with lugs on the femoralimplant.

It is also possible for the lug block to hold a removable locatorsimilar to [a_13](see FIG. 28 ) within a bore [a_25] (see FIG. 32 )which is similar to [a_14] (FIG. 29 ). Although not shown in FIG. 32 ,this removable locator may be locked into place with similar means tothat described previously. Also, if the removable locator is deemedunnecessary it is possible for the distal cut block to hold a lug blocksimilar to [a_19] that sits exactly on the femur after the distal cuthas been made in a position that has been determined during thepreoperative plan. Additional holes in the body of the distal cut blocksimilar to [a_26] may be necessary to hold the arms similar to [a_23]and [a_24] in the correct position before locking them by a screw(s)similar to [a_21].

On occasions it may be necessary to revise the distal cut (for example)of the femur for patients with a flexion contracture of the knee (forexample). In such cases a revised distal cut parallel but superior tothe first is performed. In all other respects the preparation of thepatients bone is likely to remain as planned preoperatively. FIG. 33shows a distal cutting block [a_27] that has been guided into place bythe pins [a_3] (see FIG. 28 also). Although both pins are not showncontacting the bone, the intention is for them to be locatedsufficiently deep in the bone tissue to provide (in conjunction with pin[a_4]) a means of securely fixing a template such as the one shown inFIG. 28 onto the bone. As indicated previously, the pins [a_3] areparallel to one another and the distal cut. This makes it possible toposition an additional distal cutting block [a_27] in a precise positionrelative to the patient's bone without removing the pins [a_3]. In otherwords, a first cutting block may be attached to the bone using parallelpins [a_3], and a cut may be made using the first block as a tool guide.Then, if it is decided to perform a cut at a revised position, the firstblock may be removed by sliding it off the parallel pins, and a secondblock may be slid onto the pins, that second block providing the guidemeans necessary to perform the cut at the revised position. In doing sothe surgeon is able to address the problem of patients with a flexioncontracture intraoperatively. A feature such as that indicated by [a_28]may be used to lock a handle onto the distal cutting block [a_27] whichthe surgeon or assistant may use to steady the cutting block as thedistal cut is revised.

With rapid prototyping techniques, objects are typically built in aseries of layers between 0.01 and 1.0 mm thick. This allows for theprecise construction of complex geometries. If there is sufficient spacewithin a build chamber a number of different objects can be built upsimultaneously by rapid protoyping. In certain embodiments of theinvention the custom parts of the patient specific templates aremanufactured with a rapid prototyping machine. With rapid protyping (forexample) it is possible that the manufactured custom parts may bedisorted and dimensionally inaccurate in any or all of the x, y, zdirections: these inaccuracies resulting from the manufacturing processalone. The inaccuracies may not be uniform, they may occur in aparticular direction (x, y, z) in space and even within a confinedregion of the build. FIGS. 34 and 35 illustrate locating meansmanufactured to include features enabling checks to be made easily onthe accuracy of the manufacturing process. By including a number offeatures such as those shown in FIG. 34 and FIG. 35 within the templatedesigns (for example) it is possible to quickly assess the dimensionalaccuracy of the custom parts for a given patient.

In FIG. 34 identical and prominent features are incorporated into thecustom, locating part of the template. The locating means shown in FIGS.34 a-34 c includes a generally cruciform indicator having distinct andeasily measurable dimensions. The three dimensions [a_29], [a_30] and[a_31] of the indicator structure are mutually orthogonal and should beof identical length if the manufacture has taken place properly. Thisfacilitates checking of the indicator dimensions with a go/no-go gauge.Such a gauge is adapted to engage the indicator to provide thedimensional check. It is also possible to include on certain locatingmeans features such as those shown in FIG. 35 . These features comprisepairs of indicia having separations measurable with suitable gauges orother means. In the example shown in FIGS. 35 a-35 c , the dimensions[a_32], [a_33] and [a_34] (each corresponding to a separation between arespective pair of indicia) are orthogonal to one another, enabling theaccuracy of manufacturing to be determined in all three dimensions.

When manufacturing the locating means it is also possible to include anindicator or indicator structure, separate but attached to the locatingmeans, and having features such as those shown in FIG. 36 . The part orindicator [a_35] consists of fingers of nominally identical length whichare orthogonal to one another. The lengths of these fingers can easilybe checked before the locating means is used in a surgical procedure. Ifthe fingers are all the same, correct length, then the co-manufacturedlocating means will also be dimensionally correct in three dimensions.This allows a means of checking the dimensional accuracy of the customparts similar to that already described. In certain embodimentsindicator [a_35] may be joined to the custom locating parts by a thinrod (formed during the rapid prototyping process). This would also allowthe dimensional accuracy of the manufactured parts to be checked. Oncechecked the component can be detached by breaking the rod. It may alsobe appropriate to include a unique identifier [a_36] on such parts whichrelates it uniquely to the given custom parts. With such an identifierit may not be necessary to physically link the custom parts with partssuch as [a_35]. However it may be appropriate for a known spatialrelationship to exists between the custom parts and the parts that allowtheir dimensional accuracy to be checked.

With regard to surgical methods and prosthesis fitting methods embodyingthe invention, it will be appreciated that because the locators incertain embodiments are designed on the basis of CT scans, to sit onbone, during the operation if there is any cartilage residue at the siteof these locators then that cartilage residue should be removed beforelocating and securing the template system, otherwise the accuracy of thecut(s) and/or hole(s) using the template would be affected.

From the above description it will be appreciated that certainembodiments of the present invention relate to methods, systems anddevices for facilitating total knee replacement surgery, particularly inrespect of making the bone cuts in the knee bones so these are made toallow the prosthetic components to be implanted accurately and in thecorrect orientation within the joint of the recipient. Certainembodiments of the present invention comprise template systems that arecustomised for total knee replacement surgery via large incisions aswell as those for minimally invasive surgery in which it is aimed toprepare the bone cuts and implant the prosthetic components through thesmallest possible incisions in the joint. This reduces the trauma to thesurrounding tissues, and speeds up the recovery of the patient.

We claim:
 1. A system comprising: a metal saw guide having a slottherein adapted to receive and guide a saw; a plastic body; and aplurality of plastic locating members that extend from the plastic body,wherein at least one plastic locating member of the plurality of plasticlocating members is patient-specific, wherein each plastic locatingmember has a respective bone-engaging surface that conforms to acorresponding surface of a femur, wherein the metal saw guide isnon-adjustably attachable to the plastic body, wherein each plasticlocating member is further adapted to conform against the correspondingsurface of the femur to place the metal saw guide in a fixed positionrelative to the femur, and wherein at least one of the plastic locatingmembers of the plurality of plastic locating members is adapted toengage a non-articular surface of the femur.
 2. The system of claim 1,further comprising a plurality of metal sleeves, each sleeve lining arespective bore of each plastic locating member.
 3. The system of claim2, further comprising a plurality of pins adapted to extend through theplurality of metal sleeves and into the femur.
 4. The system of claim 1,wherein at least two plastic locating members of the plurality ofplastic locating members are spaced apart from each other.
 5. The systemof claim 1, wherein at least one of the plastic locating members of theplurality of plastic locating members is adapted to engage anon-articular surface of the femur.
 6. The system of claim 1, whereinthe metal saw guide accepts a saw blade.
 7. A system comprising: a metalsaw guide having a slot therein adapted to receive and guide a saw; aplastic body; and a plurality of plastic locating members that extendfrom the plastic body, wherein at least one plastic locating member ofthe plurality of plastic locating members is patient-specific, whereineach plastic locating member has a respective bone-engaging surface thatconforms to a corresponding surface of a femur, wherein at least one ofthe plastic locating members of the plurality of plastic locatingmembers is adapted to engage an articular surface of the femur, whereinthe metal saw guide is non-adjustably attachable to the plastic body,and wherein each plastic locating member is further adapted to conformagainst the corresponding surface of the femur to place the metal sawguide in a fixed position relative to the femur.
 8. The system of claim7, wherein each plastic locating member has a bore extendingtherethrough.
 9. The system of claim 8, further comprising a pluralityof pins adapted to extend through the plurality of metal sleeves andinto the femur.
 10. The system of claim 8, further comprising aplurality of metal sleeves, each sleeve lining a respective bore of eachplastic locating member.
 11. The system of claim 10, wherein at leasttwo plastic locating members of the plurality of plastic locatingmembers are spaced apart from each other.
 12. The system of claim 10,wherein at least one of the plastic locating members of the plurality ofplastic locating members is adapted to engage a non-articular surface ofthe femur.
 13. The system of claim 10, wherein the metal saw guideaccepts a saw blade.
 14. An orthopedic surgical template system forpreparing a femur to receive a femoral component of prosthetic knee, thesystem comprising: a metal saw guide comprising at least one slot toreceive and guide a saw blade for cutting the femur; a patient-specificorienting component comprising a polymeric body portion and a pluralityof polymeric locating members that extend from and are integral with thebody portion, each locating member having a respective bone-engagingsurface adapted to conform to a corresponding portion of a predeterminedsurface of the femur, each locating member having a bore extendingthrough the member; a plurality of metal sleeves, each sleeve beingdisposed in a respective bore of a locating member; and a plurality ofpins adapted to extend through the metal sleeves and into the femur toassist in securing the patient-specific orienting component relative tothe femur; wherein the saw guide is non-adjustably attachable to thepatient-specific orienting component such that the saw guide is securedin a fixed position with respect to the locating members and such thatwhen the locating members are placed against different respectiveportions of the predetermined surface of the femur and secured in placeby pins that are extended into the femur, the slot of the saw guide islocated at a predetermined position for receiving and guiding the sawfor cutting off a distal portion of the femur, and wherein thepatient-specific orienting component further comprises a protrusionintegral with and extending from the body portion, wherein theprotrusion is adapted to engage a corresponding portion of thepredetermined surface of the femur, wherein the protrusion does not havea bore.
 15. The system of claim 14, wherein the locating members extendfrom the body portion a greater distance than the protrusion.
 16. Thesystem of claim 14, wherein the bone engaging surfaces are spaced apartfrom each other such that when the patient-specific orienting componentis secured to the femur, portions of the predetermined surface of thefemur between the bone engaging surfaces are not engaged by any portionof the patient-specific orienting component.
 17. The system of claim 14,wherein the predetermined surface of the femur is an articular surfaceof the femur and the bone engaging surfaces are adapted to engagecorresponding different portions of the articular surface of the femur.18. The system of claim 14, wherein the body portion is adapted to facea non-articular surface of the femur when the patient-specific orientingcomponent is secured to the femur.
 19. An orthopedic surgical templatesystem for preparing a femur to receive a femoral component of aprosthetic knee, the system comprising: a metal saw guide comprising atleast one slot to receive and guide a saw blade for cutting the femur; apolymeric patient-specific orienting component comprising a plurality ofpolymeric locating members, each locating member having a respectivebone-engaging surface adapted to conform to a corresponding portion of apredetermined surface of the femur; a plurality of metal sleeves, eachsleeve being disposed in a respective bore of the patient-specificorienting component; and a plurality of pins adapted to extend throughthe metal sleeves and into a non-articular surface of the femur toassist in securing the patient-specific orienting component relative tothe femur; wherein the saw guide is non-adjustably attachable to thepatient-specific orienting component such that the saw guide issecurable in a fixed position with respect to the locating members andsuch that when the locating members are placed against differentrespective portions of the predetermined surface of the femur andsecured in placed by extending the pins into the non-articular surfaceof the femur, the slot of the saw guide is located at a predeterminedposition for receiving and guiding the saw for cutting off a distalportion of the femur and wherein the patient-specific orientingcomponent further comprises a protrusion integral with and extendingfrom the body portion, wherein the protrusion is adapted to engage acorresponding portion of the predetermined surface of the femur, whereinthe protrusion does not have a bore.
 20. The system of claim 19, whereinthe bores are formed in the locating members.
 21. The system of claim19, wherein the locating members extend from the body portion a greaterdistance than the protrusion.
 22. The system of claim 19, wherein thebone engaging surfaces are spaced apart from each other such that whenthe patient-specific orienting component is secured to the femur,portions of the predetermined surface of the femur between the boneengaging surfaces are not engaged by any portion of the patient-specificorienting component.
 23. An orthopedic surgical template system forpreparing a femur to receive a femoral component of a prosthetic knee,the system comprising: a metal saw guide comprising at least one slot toreceive and guide a saw blade for cutting the femur; first and secondmetal drill guides to receive and guide a drill bit for drilling holesin the femur; and a polymeric patient-specific orienting componentcomprising a plurality of locating members, each locating member havinga respective bone-engaging surface that conforms to a correspondingportion of a predetermined surface of the femur; wherein the saw guideand the first and second drill guides are non-adjustably attachable tothe patient-specific orienting component such that the saw guide and thefirst and second drill guides are securable in fixed positions withrespect to the locating members and such that when the locating membersare placed against different respective portions of the predeterminedsurface of the femur, the slot of the saw guide is located at apredetermined position for receiving and guiding the saw for cutting offa distal portion of the femur to form a flat surface on the end of femurand the first and second drill guides are located at predeterminedpositions for drilling first and second holes in an articular surface ofthe femur, and wherein the saw guide comprises a first saw guide and thesystem further comprises a second metal saw guide comprising at leastone slot and first and second locating protrusions, wherein second sawguide is adapted to be placed against the flat surface on the femur withthe first and second locating protrusions inserted into the first andsecond holes when the patient-specific orienting component and the firstsaw guide are removed from the femur.
 24. The system of claim 23,wherein the patient-specific orienting component comprises a pluralityof bores and the assembly further comprises a plurality of pins adaptedto be inserted through the bores and into the femur.
 25. The system ofclaim 24, wherein the bores are located on the patient-specificorienting component at positions to direct the pins into a non-articularsurface of the femur.
 26. The system of claim 25, further comprising aplurality of metal sleeves, each sleeve being disposed in a respectivebore.